Red Cell Storage Duration Study

Cardiac Surgery Clinical Trial

— RECESS  

Official title:

Red Cell Storage Duration Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991341
• Other study ID #: 676
• Secondary ID: U01HL072268HL072
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2009
• Last updated: May 22, 2015
• Start date: January 2010
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The RECESS study will compare the effects of transfusing red blood cell units stored <= 10 days vs. red blood cell units stored >= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1481
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• >= 12 years old

• >= 40 kg body weight

• Scheduled complex cardiac surgery with planned use of median sternotomy.

• Patients = 18 years must have a Transfusion Risk Understanding Scoring Tool (TRUST) probability score = 3

Exclusion Criteria:

• Refusal of blood products

• Planned surgery is minimally invasive

• Known transfusion reaction history

• Requirement for washed products, volume reduced products, or products with additive solution removed

• Expected residual cyanosis with O2 saturation < 90

• Left ventricular assist device (LVAD) or Extracorporeal membrane oxygenation (ECMO) support pre-operatively or planned need post-operatively

• Cardiogenic shock requiring pre-operative placement of an Intra-aortic balloon pump (IABP) (IABP done for unstable angina or prophylactically for low ejection fraction is not excluded)

• Planned Deep Hypothermic Circulatory Arrest (DHCA)

• Renal dysfunction requiring pre-operative renal replacement therapies such as hemodialysis (HD) or continuous venovenous hemofiltration (CVVH)

• Planned use of alternative to heparin, e.g. bivalirudin

• Planned use of autologous or directed donations

• Prior RBC transfusion during hospitalization for the study-qualifying surgery

• Prior randomization into the RECESS study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Erythrocyte Transfusion

Intervention

Biological:
• 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
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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	UT Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Sanford Heart Center	Fargo	North Dakota
United States	Indiana/Ohio Heart	Fort Wayne	Indiana
United States	St. Joseph Hospital	Fort Wayne	Indiana
United States	University of Florida	Gainesville	Florida
United States	Texas Heart Institute	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Aurora St. Lukes Medical Center	Milwaukee	Wisconsin
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Fairview Southdale Hospital/University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Columbia University Health Center	New York	New York
United States	Weill Cornell Medical School	New York	New York
United States	Newark Beth Israel Deaconess Medical Center	Newark	New Jersey
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Pittsburgh Presbyterian and Shadyside	Pittsburgh	Pennsylvania
United States	UPMC-Mercy Hospital	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Swedish Medical Center	Seattle	Washington
United States	Veterans Administration Puget Sound	Seattle	Washington
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Aspirus Vascular Heart Center	Wausau	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
New England Research Institutes	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	The follow-up MODS used to calculate 7-day ?MODS 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 ?MODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).	Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	All-cause Mortality	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.	28 days post-surgery	No
Secondary	Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.	The follow-up MODS used to calculate 28-day ?MODS 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 ?MODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).	Through 28 days post-surgery, hospital discharge, or death, whichever occurs first	No
Secondary	Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)		Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)		Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
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)		Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	Ventilation Duration	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.	Through post-operative day 28, hospital discharge, or death, whichever occurs first	No
Secondary	Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value		Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	Change in Troponin-I From Pre-operative Value to Worst Post-operative Value		Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	Change in Lactate From Pre-operative Value to Worst Post-operative Value	The arterial lactate levels were adjusted to make them comparable to venous lactate levels.	Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	Change in Bilirubin From Pre-operative Value to Worst Post-operative Value		Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)		Through post-operative day 7, hospital discharge, or death, whichever occurs first	No
Secondary	Days to First Bowel Movement	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.	Through post-operative day 28, hospital discharge, or death, whichever occurs first	No
Secondary	Days to First Solid Food	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.	Through post-operative day 28, hospital discharge, or death, whichever occurs first	No
Secondary	Days Alive and Ventilator Free Through Post-op Day 28		Through post-op day 28	No
Secondary	Any Mechanical Ventilation More Than 48 Hours Post-operation		48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first	No