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

October 7, 2009
May 22, 2015
January 2010
March 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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).
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00991341 on ClinicalTrials.gov Archive Site
  • All-cause Mortality [ Time Frame: 28 days post-surgery ] [ Designated as safety issue: No ]
    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.
  • Change in Multiple Organ Dysfunction Score From Pre-operative Baseline. [ Time Frame: Through 28 days post-surgery, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Ventilation Duration [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    The arterial lactate levels were adjusted to make them comparable to venous lactate levels.
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Days to First Bowel Movement [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
    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.
  • Days to First Solid Food [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
    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.
  • Days Alive and Ventilator Free Through Post-op Day 28 [ Time Frame: Through post-op day 28 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 28 days post-surgery ] [ Designated as safety issue: No ]
  • Change in Multiple Organ Disfunction Score from pre-operative baseline. [ Time Frame: Through 28 days post-surgery, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Composite of major pulmonary events (need for mechanical ventilation more than 48 hours post-operation, or pulmonary embolism) [ Time Frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • Ventilation duration [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • Use of any mechanical ventilation more than 48 hours post-operatively [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Days to first bowel movement [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • Days to first solid food [ Time Frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • Change in Mini-Mental State Exam from pre-operative value [ Time Frame: 3 days post-operation ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Red Cell Storage Duration Study
Red Cell Storage Duration Study

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cardiac Surgery
  • Erythrocyte Transfusion
  • 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.
  • Biological: 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.
  • Active Comparator: Shorter-storage red blood cell units
    Red blood cell units stored <= 10 days
    Intervention: Biological: Red blood cell units stored <= 10 days
  • Active Comparator: Longer-storage red blood cell units
    Red blood cell units stored >= 21 days
    Intervention: Biological: Red blood cell units stored >= 21 days

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1481
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00991341
676, U01HL072268, HL072268, HL072033, HL072291, HL072196, HL072289, HL072248, HL072191, HL072299, HL072305, HL072274, HL072028, HL072359, HL072072, HL072355, HL072283, HL072346, HL072331, HL072290
Yes
New England Research Institutes
New England Research Institutes
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Susan F Assmann, PhD New England Research Institutes
Principal Investigator: Steven Sloan, MD Children's Hospital Boston
Principal Investigator: Thomas Ortel, MD Duke University
Principal Investigator: Cassandra Josephson, MD Emory University
Principal Investigator: Christopher Stowell, MD Massachusetts General Hospital
Principal Investigator: Meghan Delaney, DO University of Washington/Fred Hutchinson Cancer Research Center
Principal Investigator: Marie Steiner, MD University of Minnesota Medical Center Fairview
Principal Investigator: Darrell Triulzi, MD University of Pittsburgh Presbyterian and Shadyside
Principal Investigator: Lynne Uhl, MD Beth Israel Deaconess Medical Center
Principal Investigator: Richard Kaufman, MD Brigham and Women's Hospital
Principal Investigator: James Bussel, MD Weill Medical College of Cornell University
Principal Investigator: Paul Ness, MD Johns Hopkins University
Principal Investigator: Thomas Raife, MD University of Iowa
Principal Investigator: Rhonda Cooke, MD University of Maryland
Principal Investigator: Nigel Key, MD University of North Carolina, Chapel Hill
Principal Investigator: Jeff Carson, MD Rutgers, The State University of New Jersey
Principal Investigator: Vincent Scavo, MD Indiana/Ohio Heart
Principal Investigator: Wade Fischer, MD, FACS Froedtert Memorial Lutheran Hospital
Principal Investigator: Pampee Young, MD Vanderbilt University
Principal Investigator: Kathy Puca, MD St Luke's Hospital
Principal Investigator: James George, MD University of Oklahoma
Principal Investigator: Gregory Nuttall, MD Mayo Clinic
Principal Investigator: Arthur Bracey, MD Texas Heart Institute
Principal Investigator: Richard Engleman, MD Baystate Medical Center
Principal Investigator: Philip Greileich, MD University of Texas
Principal Investigator: Kent Berg, MD University of Florida
Principal Investigator: Robert Hunsaker, MD St. Elizabeth's Medical Center
Principal Investigator: Ronald Miles, MD Aspirus Medical Center
Principal Investigator: Ravindra Karanam, MD Barnabas Health, Newark Beth Israel Medical Center
Principal Investigator: Cornelius Dyke, MD Sanford Heart Center
Principal Investigator: Eldad Hod, MD Columbia University Health Center
New England Research Institutes
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP