Red Cell Storage Duration Study (RECESS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00991341
First received: October 7, 2009
Last updated: May 22, 2015
Last verified: May 2014
Results First Received: February 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
RECESS recruitment took place at 33 US hospitals, beginning in January 2010 and ending in January 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Shorter-storage Red Blood Cell Units

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.

Longer-storage Red Blood Cell Units

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.


Participant Flow:   Overall Study
    Shorter-storage Red Blood Cell Units     Longer-storage Red Blood Cell Units  
STARTED     742     739  
COMPLETED     538     560  
NOT COMPLETED     204     179  
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
Shorter-storage Red Blood Cell Units

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.

Longer-storage Red Blood Cell Units

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 Total of all reporting groups

Baseline Measures
    Shorter-storage Red Blood Cell Units     Longer-storage Red Blood Cell Units     Total  
Number of Participants  
[units: participants]
  538     560     1098  
Age  
[units: years]
Median (Inter-Quartile Range)
  73   (66 to 80)     72   (65 to 79)     72   (66 to 79)  
Age, Customized  
[units: participants]
     
<18 years     2     2     4  
>= 18 years     536     558     1094  
Gender  
[units: participants]
     
Female     310     313     623  
Male     228     247     475  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     13     19     32  
Not Hispanic or Latino     506     513     1019  
Unknown or Not Reported     19     28     47  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     1     2  
Asian     11     8     19  
Native Hawaiian or Other Pacific Islander     3     1     4  
Black or African American     32     39     71  
White     485     493     978  
More than one race     2     3     5  
Unknown or Not Reported     4     15     19  
Region of Enrollment  
[units: participants]
     
United States     538     560     1098  
Weight  
[units: kg]
Median (Inter-Quartile Range)
  75   (65 to 89)     74   (66 to 86)     75   (66 to 87)  
Height  
[units: cm]
Median (Inter-Quartile Range)
  165   (158 to 173)     165   (160 to 175)     165   (158 to 173)  
Minimum TRUST Score [1]
[units: 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  
ICU Status at Randomization  
[units: participants]
     
In ICU Before Surgery     34     33     67  
Not in ICU Before Surgery     504     527     1031  
Baseline Multiple Organ Dysfunction Score [2]
[units: 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  
ABO Blood Group  
[units: participants]
     
O     209     235     444  
A     240     241     481  
B     64     63     127  
AB     25     21     46  
Hemoglobin  
[units: g/L]
Median (Inter-Quartile Range)
  11.7   (10.7 to 12.8)     12.0   (10.8 to 13.0)     11.9   (10.7 to 12.9)  
[1] 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.
[2] 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.



  Outcome Measures
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1.  Primary:   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.   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

2.  Secondary:   All-cause Mortality   [ Time Frame: 28 days post-surgery ]

3.  Secondary:   Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.   [ Time Frame: Through 28 days post-surgery, hospital discharge, or death, whichever occurs first ]

4.  Secondary:   Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

5.  Secondary:   Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

6.  Secondary:   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)   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

7.  Secondary:   Ventilation Duration   [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ]

8.  Secondary:   Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

9.  Secondary:   Change in Troponin-I From Pre-operative Value to Worst Post-operative Value   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

10.  Secondary:   Change in Lactate From Pre-operative Value to Worst Post-operative Value   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

11.  Secondary:   Change in Bilirubin From Pre-operative Value to Worst Post-operative Value   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

12.  Secondary:   Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)   [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ]

13.  Secondary:   Days to First Bowel Movement   [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ]

14.  Secondary:   Days to First Solid Food   [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ]

15.  Secondary:   Days Alive and Ventilator Free Through Post-op Day 28   [ Time Frame: Through post-op day 28 ]

16.  Secondary:   Any Mechanical Ventilation More Than 48 Hours Post-operation   [ Time Frame: 48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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
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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:  
Name/Title: Susan Assmann, PhD
Organization: New England Research Institutes
phone: 617-972-3048
e-mail: sassmann@neriscience.com


No publications provided by New England Research Institutes

Publications automatically indexed to this study:

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00991341     History of Changes
Other Study ID Numbers: 676, U01HL072268, HL072268, HL072033, HL072291, HL072196, HL072289, HL072248, HL072191, HL072299, HL072305, HL072274, HL072028, HL072359, HL072072, HL072355, HL072283, HL072346, HL072331, HL072290
Study First Received: October 7, 2009
Results First Received: February 17, 2015
Last Updated: May 22, 2015
Health Authority: United States: Federal Government