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Red Cell Storage Duration Study (RECESS)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
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 
Overall Participants Analyzed 
[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]
     
 1   0   1 
 166   222   388 
 210   196   406 
 132   113   245 
 26   27   53 
 3   2   5 
[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.
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 [1] 
[Units: Participants]
     
 252   293   545 
 223   194   417 
 48   57   105 
 10   11   21 
 4   4   8 
 1   1   2 
[1] 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 
[Units: Participants]
     
 209   235   444 
 240   241   481 
 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) 


  Outcome Measures
  Show All Outcome Measures

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


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

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00991341     History of Changes
Other Study ID Numbers: 676
U01HL072268 ( US NIH Grant/Contract Award Number )
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