Red Cell Storage Duration Study (RECESS)

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ClinicalTrials.gov Identifier: NCT00991341

Recruitment Status : Completed

First Posted : October 8, 2009

Results First Posted : June 9, 2015

Last Update Posted : June 9, 2015

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

HealthCore-NERI

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Cardiac Surgery Erythrocyte Transfusion
Interventions	Biological: Red blood cell units stored <= 10 days Biological: Red blood cell units stored >= 21 days
Enrollment	1481

Participant Flow

Recruitment Details	RECESS recruitment took place at 33 US hospitals, beginning in January 2010 and ending in January 2014.
Pre-assignment Details	Randomization was stratified by age (≥18 yrs or <18 yrs) and by whether or not the subject was in the ICU prior to surgery. A subject could not be randomized unless prior to surgery but no earlier than one calendar day prior to surgery, the transfusion service had enough suitable units of both storage durations to satisfy the cross-match request.


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Period Title: Overall Study
Started	742	739
Completed	538	560
Not Completed	204	179
Reason Not Completed
no surgery w/in 30 days of randomization	11	18
Death	3	0
no RBCs received 96hrs after randomized	186	155
Physician Decision	1	2
Withdrawal by Subject	3	4

Baseline Characteristics

Arm/Group Title		Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units	Total
Arm/Group Description		Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...	Total of all reporting groups
Arm/Group Description		Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Total of all reporting groups
Overall Number of Baseline Participants		538	560	1098
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).
Age, Continuous Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	538 participants	560 participants	1098 participants
		73 (66 to 80)	72 (65 to 79)	72 (66 to 79)
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	538 participants	560 participants	1098 participants
<18 years		2	2	4
>= 18 years		536	558	1094
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	560 participants	1098 participants
	Female	310 57.6%	313 55.9%	623 56.7%
	Male	228 42.4%	247 44.1%	475 43.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	560 participants	1098 participants
	Hispanic or Latino	13 2.4%	19 3.4%	32 2.9%
	Not Hispanic or Latino	506 94.1%	513 91.6%	1019 92.8%
	Unknown or Not Reported	19 3.5%	28 5.0%	47 4.3%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	538 participants	560 participants	1098 participants
	American Indian or Alaska Native	1 0.2%	1 0.2%	2 0.2%
	Asian	11 2.0%	8 1.4%	19 1.7%
	Native Hawaiian or Other Pacific Islander	3 0.6%	1 0.2%	4 0.4%
	Black or African American	32 5.9%	39 7.0%	71 6.5%
	White	485 90.1%	493 88.0%	978 89.1%
	More than one race	2 0.4%	3 0.5%	5 0.5%
	Unknown or Not Reported	4 0.7%	15 2.7%	19 1.7%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	538 participants	560 participants	1098 participants
United States		538	560	1098
Weight Median (Inter-Quartile Range) Unit of measure: Kg
	Number Analyzed	538 participants	560 participants	1098 participants
		75 (65 to 89)	74 (66 to 86)	75 (66 to 87)
Height Median (Inter-Quartile Range) Unit of measure: Cm
	Number Analyzed	538 participants	560 participants	1098 participants
		165 (158 to 173)	165 (160 to 175)	165 (158 to 173)
Minimum TRUST Score ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	538 participants	560 participants	1098 participants
0		1	0	1
3		166	222	388
4		210	196	406
5		132	113	245
6		26	27	53
7		3	2	5
		[1] Measure Description: Per Alghamdi et al article in Transfusion (2006), the Transfusion Risk Understanding Scoring Tool (TRUST) score is an additive algorithm that provides an overall score that ranges from 0 to 8. The interpretation of the total score as it relates to the probability of exposure to transfusion is as follows: 0=baseline risk; 1=low risk; 2=intermediate risk; 3=high risk; 4-8=very high risk.
ICU Status at Randomization Measure Type: Number Unit of measure: Participants	Number Analyzed	538 participants	560 participants	1098 participants
In ICU Before Surgery		34	33	67
Not in ICU Before Surgery		504	527	1031
Baseline Multiple Organ Dysfunction Score ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	538 participants	560 participants	1098 participants
0		252	293	545
1		223	194	417
2		48	57	105
3		10	11	21
4		4	4	8
5		1	1	2
		[1] Measure Description: Per Marshall et al article in Critical Care Medicine (1995), increasing Multiple Organ Dysfunction Scores correlated with in-hospital mortality. No deaths occurred in patients with a MODS score of 0. The approximate in-hospital mortality rates were 6% for patients with MODS score of 1-4 points, 15% for patients with scores between 5-8, 50% for patients with scores between 8-12, 68% for patients with scores 13-16, 80% for patients with scores 17-20 and 100% for scores > 20.
ABO Blood Group Measure Type: Number Unit of measure: Participants	Number Analyzed	538 participants	560 participants	1098 participants
O		209	235	444
A		240	241	481
B		64	63	127
AB		25	21	46
Hemoglobin Median (Inter-Quartile Range) Unit of measure: g/L
	Number Analyzed	538 participants	560 participants	1098 participants
		11.7 (10.7 to 12.8)	12.0 (10.8 to 13.0)	11.9 (10.7 to 12.9)

Outcome Measures

1.Primary Outcome


Title	The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.
Description	The follow-up MODS used to calculate 7-day ΔMODS from pre-op base...
Description	The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description

Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	534	553
Mean (Standard Deviation) Unit of Measure: MOD score points
	8.49 (3.62)	8.66 (3.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.44
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95% -0.60 to 0.26
	Estimation Comments	The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.

2.Secondary Outcome


Title	All-cause Mortality
Description	Subjects were randomized for RECESS no earlier than one calendar day b...
Description	Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.
Time Frame	28 days post-surgery

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	538	560
Measure Type: Number Unit of Measure: participants with event
	23	29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.50
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	The treatment groups were compared with respect to all-cause mortality, adjusting for baseline MODS.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95% 0.48 to 1.43
	Estimation Comments	The longer storage duration arm is the reference category.

3.Secondary Outcome


Title	Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.
Description	The follow-up MODS used to calculate 28-day ΔMODS from pre-op bas...
Description	The follow-up MODS used to calculate 28-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 28, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 28-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).
Time Frame	Through 28 days post-surgery, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	531	555
Mean (Standard Deviation) Unit of Measure: MOD score points
	8.74 (4.04)	9.07 (4.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.20
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	The treatment groups were compared with respect to 28-day change in MODS, adjusting for baseline MODS.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95% -0.82 to 0.17
	Estimation Comments	The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.32; positive values are in favor of longer storage duration.

4.Secondary Outcome


Title	Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	448	470
Measure Type: Number Unit of Measure: participants with event
	91	87

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.50
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.018
	Confidence Interval	(2-Sided) 95% -0.033 to 0.069
	Estimation Comments	The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.

5.Secondary Outcome


Title	Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	472	496
Measure Type: Number Unit of Measure: participants with event
	206	230

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.40
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.027
	Confidence Interval	(2-Sided) 95% -0.090 to 0.035
	Estimation Comments	The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.

6.Secondary Outcome


Title	Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	508	537
Measure Type: Number Unit of Measure: participants with event
	62	75

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.41
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.018
	Confidence Interval	(2-Sided) 95% -0.059 to 0.023
	Estimation Comments	The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.

7.Secondary Outcome


Title	Ventilation Duration
Description	Because some subjects may experience multiple periods of ventilator us...
Description	Because some subjects may experience multiple periods of ventilator use, the total duration that they were on a ventilator was compared between the two groups.
Time Frame	Through post-operative day 28, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	514	540
Mean (Standard Deviation) Unit of Measure: days
	2.7 (3.9)	2.8 (4.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.75
	Comments	[Not Specified]
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.12
	Confidence Interval	(2-Sided) 95% -0.62 to 0.37
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	532	558
Mean (Standard Deviation) Unit of Measure: mg/dL
	0.35 (0.58)	0.35 (0.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.62
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	The treatment arms were compared with respect to the change in creatinine, adjusting for the baseline creatinine value.

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95% -0.08 to 0.05
	Estimation Comments	The longer storage red blood cell units arm is the reference category. After adjusting for baseline creatinine, the difference in the means was -0.02, positive values are in favor of longer storage duration.

9.Secondary Outcome


Title	Change in Troponin-I From Pre-operative Value to Worst Post-operative Value
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	443	470
Mean (Standard Deviation) Unit of Measure: ng/mL
	15.82 (37.64)	14.06 (23.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.35
	Comments	The treatment arms were compared with respect to the change in troponin-I, adjusting for the baseline troponin-I value.
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.93
	Confidence Interval	(2-Sided) 95% -2.11 to 5.98
	Estimation Comments	The longer storage red blood cell units arm is the reference category. After adjusting for baseline troponin-I, the change in troponin-I values was 1.9 ng/mL higher in the shorter storage red blood cell units arm.

10.Secondary Outcome


Title	Change in Lactate From Pre-operative Value to Worst Post-operative Value
Description	The arterial lactate levels were adjusted to make them comparable to v...
Description	The arterial lactate levels were adjusted to make them comparable to venous lactate levels.
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	410	437
Mean (Standard Deviation) Unit of Measure: mmol/L
	2.30 (3.33)	2.92 (5.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.10
	Comments	[Not Specified]
	Method	Kruskal-Wallis
	Comments	[Not Specified]

11.Secondary Outcome


Title	Change in Bilirubin From Pre-operative Value to Worst Post-operative Value
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	513	543
Mean (Standard Deviation) Unit of Measure: mg/dL
	0.85 (1.24)	1.49 (2.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.01
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.65
	Confidence Interval	(2-Sided) 95% -0.89 to -0.41
	Estimation Comments	The longer storage red blood cell units arm is the reference category. After adjusting for baseline bilirubin, the change in bilirubin values was 0.65 mg/dL lower in the shorter storage red blood cell units arm.

12.Secondary Outcome


Title	Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-operative day 7, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description

Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT. Therefore, to protect patient confidentiality, results were not entered.


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

13.Secondary Outcome


Title	Days to First Bowel Movement
Description	Subjects were randomized for RECESS no earlier than one calendar day b...
Description	Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative bowel movement.
Time Frame	Through post-operative day 28, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	538	560
Mean (Standard Error) Unit of Measure: days
	5.89 (0.17)	6.62 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.11
	Comments	The treatment groups were compared with respect to days to first post-operative bowel movement, adjusting for baseline MODS.
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95% 0.98 to 1.25
	Estimation Comments	The longer storage duration arm is reference category.

14.Secondary Outcome


Title	Days to First Solid Food
Description	Subjects were randomized for RECESS no earlier than one calendar day b...
Description	Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative solid food.
Time Frame	Through post-operative day 28, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	538	560
Mean (Standard Error) Unit of Measure: days
	5.73 (0.37)	6.18 (0.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.22
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	The treatment groups were compared with respect to days to first post-operative solid food, adjusting for baseline MODS.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.08
	Confidence Interval	(2-Sided) 95% 0.96 to 1.22
	Estimation Comments	The longer storage duration arm is reference category.

15.Secondary Outcome


Title	Days Alive and Ventilator Free Through Post-op Day 28
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Through post-op day 28

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	511	539
Mean (Standard Deviation) Unit of Measure: days
	25.38 (6.40)	25.17 (6.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.71
	Comments	[Not Specified]
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95% -0.59 to 1.00
	Estimation Comments	The longer storage duration arm is reference category.

16.Secondary Outcome


Title	Any Mechanical Ventilation More Than 48 Hours Post-operation
Description	[Not Specified]
Description	[Not Specified]
Time Frame	48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Shorter-storage Red Blood Cell Units	Longer-storage Red Blood Cell Units
Arm/Group Description:	Red blood cell units stored <= 10 d...	Red blood cell units stored >= 21 d...
Arm/Group Description:	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.	Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Overall Number of Participants Analyzed	508	537
Measure Type: Number Unit of Measure: participants with event
	68	80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Shorter-storage Red Blood Cell Units, Longer-storage Red Blood Cell Units
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.53
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) 95% -0.057 to 0.027
	Estimation Comments	The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.

Adverse Events

Time Frame	Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than post-operative day 28, hospital discharge, or death, whichever came first.
Adverse Event Reporting Description	Data were collected on all serious adverse events (SAEs) and on pre-specified types of non-serious adverse events. If a subject experiences more than one occurrence of a specific adverse event, the subject was counted only once for that adverse event.

Arm/Group Title	Shorter-storage Red Blood Cell Units		Longer-storage Red Blood Cell Units
Arm/Group Description	Red blood cell units stored <= 10 d...		Red blood cell units stored >= 21 d...
Arm/Group Description	Red blood cell units stored <= 10 days Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.		Red blood cell units stored >= 21 days Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
All-Cause Mortality
	Shorter-storage Red Blood Cell Units		Longer-storage Red Blood Cell Units
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Shorter-storage Red Blood Cell Units		Longer-storage Red Blood Cell Units
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	283/538 (52.60%)		288/560 (51.43%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Autoimmune thrombocytopenia ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Coagulopathy ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Disseminated intravascular coagulation ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Haemolytic anaemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Heparin-induced thrombocytopenia ^† 1	5/538 (0.93%)	5	3/560 (0.54%)	3
Leukocytosis ^† 1	7/538 (1.30%)	7	4/560 (0.71%)	5
Thrombocytopenia ^† 1	1/538 (0.19%)	1	4/560 (0.71%)	4
Cardiac disorders
Accelerated idioventricular rhythm ^† 1	3/538 (0.56%)	4	0/560 (0.00%)	0
Acute coronary syndrome ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Acute myocardial infarction ^† 1	9/538 (1.67%)	9	9/560 (1.61%)	9
Acute right ventricular failure ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Angina pectoris ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Angina unstable ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Arrhythmia ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Arrhythmia supraventricular ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Atrial fibrillation ^† 1	31/538 (5.76%)	33	25/560 (4.46%)	28
Atrial flutter ^† 1	3/538 (0.56%)	3	1/560 (0.18%)	1
Atrial tachycardia ^† 1	3/538 (0.56%)	3	3/560 (0.54%)	3
Atrioventricular block ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Atrioventricular block complete ^† 1	3/538 (0.56%)	3	3/560 (0.54%)	3
Atrioventricular block first degree ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bradycardia ^† 1	7/538 (1.30%)	9	10/560 (1.79%)	10
Cardiac arrest ^† 1	3/538 (0.56%)	4	4/560 (0.71%)	4
Cardiac disorder ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Cardiac failure congestive ^† 1	2/538 (0.37%)	2	3/560 (0.54%)	3
Cardiac tamponade ^† 1	6/538 (1.12%)	6	5/560 (0.89%)	6
Cardio-respiratory arrest ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Cardiogenic shock ^† 1	9/538 (1.67%)	9	13/560 (2.32%)	13
Cardiomyopathy acute ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Conduction disorder ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Intracardiac thrombus ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Myocardial infarction ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Negative cardiac inotropic effect ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Nodal arrhythmia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Pericardial effusion ^† 1	3/538 (0.56%)	3	0/560 (0.00%)	0
Sick sinus syndrome ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Sinus bradycardia ^† 1	20/538 (3.72%)	20	24/560 (4.29%)	24
Sinus tachycardia ^† 1	16/538 (2.97%)	17	26/560 (4.64%)	28
Supraventricular tachyarrhythmia ^† 1	3/538 (0.56%)	3	2/560 (0.36%)	2
Supraventricular tachycardia ^† 1	0/538 (0.00%)	0	3/560 (0.54%)	3
Tachycardia ^† 1	0/538 (0.00%)	0	5/560 (0.89%)	6
Ventricular arrhythmia ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Ventricular asystole ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Ventricular extrasystoles ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Ventricular fibrillation ^† 1	4/538 (0.74%)	4	6/560 (1.07%)	6
Ventricular tachyarrhythmia ^† 1	3/538 (0.56%)	4	4/560 (0.71%)	4
Ventricular tachycardia ^† 1	6/538 (1.12%)	9	7/560 (1.25%)	8
Congenital, familial and genetic disorders
Familial hypocalciuric hypercalcaemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Heart block congenital ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Ear and labyrinth disorders
Vertigo ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Endocrine disorders
Antidiuretic hormone abnormality ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Eye disorders
Visual acuity reduced transiently ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Visual impairment ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Gastrointestinal disorders
Abdominal compartment syndrome ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Abdominal distension ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Ascites ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Colitis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Colonic obstruction ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Dysphagia ^† 1	3/538 (0.56%)	3	1/560 (0.18%)	1
Gastric haemorrhage ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Gastric perforation ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Gastrointestinal haemorrhage ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Ileus ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Ileus paralytic ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Internal hernia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Lower gastrointestinal haemorrhage ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Megacolon ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Mesenteric occlusion ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Oesophageal perforation ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Peritoneal haemorrhage ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Pneumoperitoneum ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Retroperitoneal haematoma ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Retroperitoneal haemorrhage ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Upper gastrointestinal haemorrhage ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
General disorders
Adverse drug reaction ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Application site bleeding ^† 1	13/538 (2.42%)	13	11/560 (1.96%)	11
Cardiac death ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Chest discomfort ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Chest pain ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Infusion related reaction ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Infusion site dermatitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Multi-organ disorder ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Multi-organ failure ^† 1	3/538 (0.56%)	3	3/560 (0.54%)	3
Pyrexia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hepatobiliary disorders
Hepatic cirrhosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hepatic ischaemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hyperbilirubinaemia ^† 1	26/538 (4.83%)	28	51/560 (9.11%)	58
Liver injury ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Pneumobilia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Immune system disorders
Anaphylactoid shock ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Infections and infestations
Abdominal infection ^† 1	1/538 (0.19%)	2	2/560 (0.36%)	2
Abdominal sepsis ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Acute endocarditis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Adenoviral upper respiratory infection ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Bacterial diarrhoea ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bacterial infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Bacterial sepsis ^† 1	3/538 (0.56%)	3	6/560 (1.07%)	6
Bronchitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Bronchitis pneumococcal ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bronchopneumonia ^† 1	11/538 (2.04%)	12	9/560 (1.61%)	9
Candida pneumonia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cellulitis ^† 1	3/538 (0.56%)	3	0/560 (0.00%)	0
Clostridium colitis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Clostridium difficile colitis ^† 1	3/538 (0.56%)	3	3/560 (0.54%)	3
Cystitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cystitis klebsiella ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Endocarditis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Enterobacter infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Enterobacter pneumonia ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Enterococcal infection ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Escherichia urinary tract infection ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Febrile infection ^† 1	1/538 (0.19%)	1	3/560 (0.54%)	3
Genitourinary tract infection ^† 1	8/538 (1.49%)	9	6/560 (1.07%)	6
Incision site infection ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Lung infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Osteomyelitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Pneumonia klebsiella ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Post procedural infection ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Postoperative wound infection ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Pseudomonal bacteraemia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Pseudomonas infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Sepsis syndrome ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Septic shock ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Serratia infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Upper respiratory tract infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Urinary tract infection ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Injury, poisoning and procedural complications
Airway complication of anaesthesia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Allergic transfusion reaction ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Anaphylactic transfusion reaction ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cardiac function disturbance postoperative ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cardiac valve replacement complication ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Confusion postoperative ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Deep vein thrombosis postoperative ^† 1	1/538 (0.19%)	1	4/560 (0.71%)	4
Endotracheal intubation complication ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Fall ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Iatrogenic injury ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Mental status changes postoperative ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Operative haemorrhage ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Pneumothorax traumatic ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Post procedural complication ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Post procedural haemorrhage ^† 1	1/538 (0.19%)	1	6/560 (1.07%)	6
Post procedural myocardial infarction ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Postoperative ileus ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Postoperative renal failure ^† 1	3/538 (0.56%)	3	3/560 (0.54%)	3
Procedural hypotension ^† 1	3/538 (0.56%)	3	9/560 (1.61%)	9
Renal injury ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Subdural haematoma ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Urinary retention postoperative ^† 1	10/538 (1.86%)	10	10/560 (1.79%)	10
Weaning failure ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Wound dehiscence ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Wound necrosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Investigations
Activated partial thromboplastin time ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Anticoagulation drug level below therapeutic ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Aspiration pleural cavity ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Bacteria blood identified ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bacteria sputum identified ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Blood gases abnormal ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Blood pressure abnormal ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Blood pressure decreased ^† 1	6/538 (1.12%)	6	5/560 (0.89%)	5
Blood pressure systolic decreased ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Blood urea nitrogen/creatinine ratio increased ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Blood urine present ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Body temperature decreased ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Body temperature increased ^† 1	2/538 (0.37%)	2	3/560 (0.54%)	3
Bronchoalveolar lavage abnormal ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cardiac enzymes increased ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Cardiac output decreased ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Clostridium difficile toxin test positive ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
ECG signs of myocardial ischaemia ^† 1	4/538 (0.74%)	4	2/560 (0.36%)	2
Ejection fraction decreased ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Fungus culture positive ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Heart rate decreased ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Heart rate increased ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
International normalised ratio abnormal ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Kidney injury molecule-1 ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Methicillin-resistant staphylococcal aureus test positive ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
NIH stroke scale ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
NIH stroke scale score increased ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Occult blood positive ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	2
Oxygen saturation ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Oxygen saturation decreased ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Pathology test ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Radial pulse abnormal ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Red blood cells urine positive ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Sputum culture positive ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Transaminases increased ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Troponin I increased ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Urine output decreased ^† 1	15/538 (2.79%)	15	18/560 (3.21%)	18
White blood cell count increased ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Metabolism and nutrition disorders
Acidosis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Feeding disorder ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Fluid overload ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Fluid retention ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypercalcaemia ^† 1	2/538 (0.37%)	2	7/560 (1.25%)	8
Hyperkalaemia ^† 1	15/538 (2.79%)	15	15/560 (2.68%)	16
Hypernatraemia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hyperphosphataemia ^† 1	5/538 (0.93%)	5	6/560 (1.07%)	6
Hyperphosphatasaemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hypervolaemia ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Hypocalcaemia ^† 1	55/538 (10.22%)	56	46/560 (8.21%)	52
Hypoglycaemia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypokalaemia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hyponatraemia ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Hypophosphataemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hypovolaemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Malnutrition ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Metabolic acidosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Metabolic alkalosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Musculoskeletal and connective tissue disorders
Compartment syndrome ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypercreatinaemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Nervous system disorders
Altered state of consciousness ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Anoxic encephalopathy ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Aphasia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Atonic seizures ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Brain stem stroke ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cerebellar infarction ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Cerebral artery embolism ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Cerebral infarction ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cerebral venous thrombosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cerebrovascular accident ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Depressed level of consciousness ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Embolic stroke ^† 1	5/538 (0.93%)	5	3/560 (0.54%)	3
Encephalopathy ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Essential tremor ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Grand mal convulsion ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hemiparesis ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Ischaemic stroke ^† 1	5/538 (0.93%)	5	2/560 (0.36%)	2
Partial seizures ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Seizure anoxic ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Serotonin syndrome ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Simple partial seizures ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Stroke in evolution ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Subarachnoid haemorrhage ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Transient ischaemic attack ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Psychiatric disorders
Adjustment disorder with depressed mood ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Confusional state ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Paranoia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Renal and urinary disorders
Acute prerenal failure ^† 1	15/538 (2.79%)	16	14/560 (2.50%)	14
Anuria ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Azotaemia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Haematuria ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Haemoglobinuria ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Oliguria ^† 1	5/538 (0.93%)	5	3/560 (0.54%)	3
Renal disorder ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Renal failure ^† 1	2/538 (0.37%)	2	5/560 (0.89%)	5
Renal failure acute ^† 1	8/538 (1.49%)	8	2/560 (0.36%)	2
Renal impairment ^† 1	2/538 (0.37%)	2	3/560 (0.54%)	3
Renal mass ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Renal tubular necrosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Urinary bladder haemorrhage ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Urinary retention ^† 1	3/538 (0.56%)	3	5/560 (0.89%)	5
Reproductive system and breast disorders
Bleeding anovulatory ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Scrotal swelling ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis ^† 1	3/538 (0.56%)	3	1/560 (0.18%)	1
Acute lung injury ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Acute pulmonary oedema ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Acute respiratory distress syndrome ^† 1	4/538 (0.74%)	4	5/560 (0.89%)	5
Acute respiratory failure ^† 1	9/538 (1.67%)	10	11/560 (1.96%)	11
Anaemic hypoxia ^† 1	3/538 (0.56%)	3	6/560 (1.07%)	6
Apnoeic attack ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Aspiration ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Atelectasis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Clotted haemothorax ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cough ^† 1	3/538 (0.56%)	3	5/560 (0.89%)	5
Dyspnoea ^† 1	27/538 (5.02%)	28	24/560 (4.29%)	25
Dyspnoea at rest ^† 1	8/538 (1.49%)	9	12/560 (2.14%)	12
Dyspnoea exertional ^† 1	6/538 (1.12%)	6	6/560 (1.07%)	6
Epistaxis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Haemothorax ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypercapnia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hypoxia ^† 1	33/538 (6.13%)	36	39/560 (6.96%)	39
Idiopathic pneumonia syndrome ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Lung consolidation ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Mediastinal disorder ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Mediastinal haematoma ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Mediastinal haemorrhage ^† 1	6/538 (1.12%)	6	6/560 (1.07%)	6
Pleural effusion ^† 1	11/538 (2.04%)	13	9/560 (1.61%)	9
Pneumothorax ^† 1	3/538 (0.56%)	3	0/560 (0.00%)	0
Pneumothorax spontaneous tension ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Pulmonary embolism ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Respiratory acidosis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Respiratory distress ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Respiratory failure ^† 1	2/538 (0.37%)	3	1/560 (0.18%)	1
Stridor ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Tachypnoea ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Thoracic haemorrhage ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Vocal cord disorder ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Wheezing ^† 1	6/538 (1.12%)	7	12/560 (2.14%)	12
Skin and subcutaneous tissue disorders
Angioedema ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Itching scar ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Pruritus allergic ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Skin ulcer ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Surgical and medical procedures
Abdominal exploration ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Allergy prophylaxis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Aneurysm repair ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Cardiac pacemaker insertion ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Dialysis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Extracorporeal membrane oxygenation ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypotensive anaesthesia procedure ^† 1	3/538 (0.56%)	3	2/560 (0.36%)	2
Incisional drainage ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Intracerebral haematoma evacuation ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Pericardial drainage ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Removal of foreign body ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Tracheostomy ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	2
Vascular disorders
Accelerated hypertension ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Aortic intramural haematoma ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Arterial thrombosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Arteriovenous fistula ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Deep vein thrombosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Diastolic hypertension ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Diastolic hypotension ^† 1	14/538 (2.60%)	14	14/560 (2.50%)	14
Essential hypertension ^† 1	5/538 (0.93%)	5	3/560 (0.54%)	3
Haematoma ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Haemodynamic instability ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Haemorrhage ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypertension ^† 1	13/538 (2.42%)	14	13/560 (2.32%)	13
Hypotension ^† 1	97/538 (18.03%)	106	87/560 (15.54%)	96
Hypovolaemic shock ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Ischaemic limb pain ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Labile hypertension ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Orthostatic hypotension ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Peripheral vascular disorder ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Poor peripheral circulation ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Venous thrombosis limb ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (12.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Shorter-storage Red Blood Cell Units		Longer-storage Red Blood Cell Units
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	324/538 (60.22%)		334/560 (59.64%)
Blood and lymphatic system disorders
Haemolysis ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Leukocytosis ^† 1	7/538 (1.30%)	7	4/560 (0.71%)	4
Cardiac disorders
Accessory cardiac pathway ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Acute myocardial infarction ^† 1	3/538 (0.56%)	3	2/560 (0.36%)	2
Arrhythmia ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Atrial fibrillation ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Atrial tachycardia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bradyarrhythmia ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Bradycardia ^† 1	4/538 (0.74%)	4	10/560 (1.79%)	10
Cardiac failure congestive ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Myocardial infarction ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Myocardial ischaemia ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Sinus bradycardia ^† 1	12/538 (2.23%)	12	11/560 (1.96%)	12
Sinus tachycardia ^† 1	25/538 (4.65%)	27	28/560 (5.00%)	28
Supraventricular tachyarrhythmia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Supraventricular tachycardia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Tachycardia ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Ventricular tachyarrhythmia ^† 1	3/538 (0.56%)	3	0/560 (0.00%)	0
Ventricular tachycardia ^† 1	7/538 (1.30%)	7	3/560 (0.54%)	3
Congenital, familial and genetic disorders
Familial hypocalciuric hypercalcaemia ^† 1	4/538 (0.74%)	4	2/560 (0.36%)	2
General disorders
Adverse reaction ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Catheter site phlebitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Chest pain ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Chills ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hyperthermia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Oedema peripheral ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Pyrexia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hepatobiliary disorders
Hyperbilirubinaemia ^† 1	78/538 (14.50%)	89	98/560 (17.50%)	107
Hyperbilirubinaemia neonatal ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Immune system disorders
Alloimmunisation ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hypersensitivity ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Infections and infestations
Acinetobacter infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Actinomycotic pulmonary infection ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Acute sinusitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Adenoviral upper respiratory infection ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Application site cellulitis ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Arteriovenous graft site infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Aspergillosis oral ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Asymptomatic bacteriuria ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bacteriuria ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bronchopneumonia ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Catheter site cellulitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Clostridium difficile colitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Cytomegalovirus urinary tract infection ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Enterobacter tracheobronchitis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Escherichia urinary tract infection ^† 1	1/538 (0.19%)	1	3/560 (0.54%)	3
Genitourinary tract infection ^† 1	10/538 (1.86%)	10	9/560 (1.61%)	10
Incision site infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Influenza ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Klebsiella bacteraemia ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Parotitis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Upper respiratory fungal infection ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Urinary tract infection ^† 1	2/538 (0.37%)	2	0/560 (0.00%)	0
Urinary tract infection bacterial ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Wound infection ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Injury, poisoning and procedural complications
Allergic transfusion reaction ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Iatrogenic injury ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Post procedural haematuria ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Postoperative renal failure ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Procedural hypotension ^† 1	3/538 (0.56%)	3	2/560 (0.36%)	2
Urethral stricture traumatic ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Urinary retention postoperative ^† 1	7/538 (1.30%)	7	10/560 (1.79%)	10
Investigations
Bacteria blood identified ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Bacteria sputum identified ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Bacteria urine ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bilirubin conjugated abnormal ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Bilirubin conjugated increased ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Blood pressure abnormal ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Blood pressure decreased ^† 1	5/538 (0.93%)	5	3/560 (0.54%)	3
Blood pressure orthostatic decreased ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Blood urine ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Body temperature increased ^† 1	8/538 (1.49%)	8	3/560 (0.54%)	3
Cardiac enzymes increased ^† 1	7/538 (1.30%)	7	9/560 (1.61%)	9
Differential white blood cell count normal ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
ECG signs of myocardial ischaemia ^† 1	7/538 (1.30%)	7	8/560 (1.43%)	8
Heart rate decreased ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Methicillin-resistant staphylococcal aureus test positive ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Oxygen saturation decreased ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Sputum culture ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Sputum culture positive ^† 1	2/538 (0.37%)	3	0/560 (0.00%)	0
Troponin ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Urine output decreased ^† 1	3/538 (0.56%)	3	1/560 (0.18%)	1
Metabolism and nutrition disorders
Fluid overload ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Fluid retention ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypercalcaemia ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Hyperkalaemia ^† 1	18/538 (3.35%)	18	18/560 (3.21%)	18
Hyperphosphataemia ^† 1	25/538 (4.65%)	30	11/560 (1.96%)	13
Hyperphosphatasaemia ^† 1	1/538 (0.19%)	1	3/560 (0.54%)	3
Hypocalcaemia ^† 1	187/538 (34.76%)	230	191/560 (34.11%)	228
Hyponatraemia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypophosphataemia ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Nervous system disorders
Aphasia ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Embolic stroke ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Haemorrhagic stroke ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Renal and urinary disorders
Acute prerenal failure ^† 1	8/538 (1.49%)	8	5/560 (0.89%)	7
Haematuria ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Haemoglobinuria ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Hypocalciuria ^† 1	3/538 (0.56%)	4	0/560 (0.00%)	0
Oliguria ^† 1	2/538 (0.37%)	2	4/560 (0.71%)	4
Renal failure ^† 1	0/538 (0.00%)	0	2/560 (0.36%)	2
Renal failure acute ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Renal impairment ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	3
Renal tubular necrosis ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Urinary incontinence ^† 1	2/538 (0.37%)	2	2/560 (0.36%)	2
Urinary retention ^† 1	5/538 (0.93%)	5	3/560 (0.54%)	3
Urine flow decreased ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Reproductive system and breast disorders
Scrotal oedema ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Anaemic hypoxia ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Bradypnoea ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Cough ^† 1	3/538 (0.56%)	3	2/560 (0.36%)	2
Dyspnoea ^† 1	10/538 (1.86%)	11	11/560 (1.96%)	11
Dyspnoea at rest ^† 1	3/538 (0.56%)	3	4/560 (0.71%)	4
Dyspnoea exertional ^† 1	15/538 (2.79%)	16	20/560 (3.57%)	20
Hypoxia ^† 1	8/538 (1.49%)	8	14/560 (2.50%)	14
Pleural effusion ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Productive cough ^† 1	3/538 (0.56%)	3	3/560 (0.54%)	3
Pulmonary embolism ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Tachypnoea ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Wheezing ^† 1	16/538 (2.97%)	17	12/560 (2.14%)	12
Skin and subcutaneous tissue disorders
Erythema ^† 1	2/538 (0.37%)	2	1/560 (0.18%)	1
Surgical and medical procedures
Haemophilus influenzae type b immunisation ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Hypotensive anaesthesia procedure ^† 1	1/538 (0.19%)	1	1/560 (0.18%)	1
Vascular disorders
Accelerated hypertension ^† 1	4/538 (0.74%)	4	5/560 (0.89%)	5
Diastolic hypertension ^† 1	2/538 (0.37%)	3	1/560 (0.18%)	1
Diastolic hypotension ^† 1	6/538 (1.12%)	6	4/560 (0.71%)	4
Essential hypertension ^† 1	1/538 (0.19%)	1	2/560 (0.36%)	2
Hypertension ^† 1	20/538 (3.72%)	20	21/560 (3.75%)	23
Hypertensive crisis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
Hypotension ^† 1	71/538 (13.20%)	76	73/560 (13.04%)	76
Orthostatic hypotension ^† 1	0/538 (0.00%)	0	1/560 (0.18%)	1
Thrombophlebitis ^† 1	1/538 (0.19%)	1	0/560 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (12.0)

Limitations and Caveats

Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT outcome. Therefore, to protect patient confidentiality, results were not entered for this outcome.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Susan Assmann, PhD
Organization:	New England Research Institutes
Phone:	617-972-3048
EMail:	sassmann@neriscience.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Delaney M, Stark PC, Suh M, Triulzi DJ, Hess JR, Steiner ME, Stowell CP, Sloan SR. Massive Transfusion in Cardiac Surgery: The Impact of Blood Component Ratios on Clinical Outcomes and Survival. Anesth Analg. 2017 Jun;124(6):1777-1782. doi: 10.1213/ANE.0000000000001926.

Steiner ME, Ness PM, Assmann SF, Triulzi DJ, Sloan SR, Delaney M, Granger S, Bennett-Guerrero E, Blajchman MA, Scavo V, Carson JL, Levy JH, Whitman G, D'Andrea P, Pulkrabek S, Ortel TL, Bornikova L, Raife T, Puca KE, Kaufman RM, Nuttall GA, Young PP, Youssef S, Engelman R, Greilich PE, Miles R, Josephson CD, Bracey A, Cooke R, McCullough J, Hunsaker R, Uhl L, McFarland JG, Park Y, Cushing MM, Klodell CT, Karanam R, Roberts PR, Dyke C, Hod EA, Stowell CP. Effects of red-cell storage duration on patients undergoing cardiac surgery. N Engl J Med. 2015 Apr 9;372(15):1419-29. doi: 10.1056/NEJMoa1414219.

Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.

Berra L, Coppadoro A, Yu B, Lei C, Spagnolli E, Steinbicker AU, Bloch KD, Lin T, Sammy FY, Warren HS, Fernandez BO, Feelisch M, Dzik WH, Stowell CP, Zapol WM. Transfusion of stored autologous blood does not alter reactive hyperemia index in healthy volunteers. Anesthesiology. 2012 Jul;117(1):56-63. doi: 10.1097/ALN.0b013e31825575e6.

Steiner ME, Assmann SF, Levy JH, Marshall J, Pulkrabek S, Sloan SR, Triulzi D, Stowell CP. Addressing the question of the effect of RBC storage on clinical outcomes: the Red Cell Storage Duration Study (RECESS) (Section 7). Transfus Apher Sci. 2010 Aug;43(1):107-16. doi: 10.1016/j.transci.2010.05.014. Epub 2010 Jul 23.

Layout table for additonal information

Responsible Party:	HealthCore-NERI
ClinicalTrials.gov Identifier:	NCT00991341
Other Study ID Numbers:	676 U01HL072268 ( U.S. NIH Grant/Contract ) HL072268 HL072033 HL072291 HL072196 HL072289 HL072248 HL072191 HL072299 HL072305 HL072274 HL072028 HL072359 HL072072 HL072355 HL072283 HL072346 HL072331 HL072290
First Submitted:	October 7, 2009
First Posted:	October 8, 2009
Results First Submitted:	February 17, 2015
Results First Posted:	June 9, 2015
Last Update Posted:	June 9, 2015

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