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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


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
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