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 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cardiac Surgery
Erythrocyte Transfusion
Biological: Red blood cell units stored <= 10 days
Biological: Red blood cell units stored >= 21 days
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Red Cell Storage Duration Study

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 (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 ]
  • 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 ]
  • 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 ]

Enrollment: 1481
Study Start Date: January 2010
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Shorter-storage red blood cell units
Red blood cell units stored <= 10 days
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.
Active Comparator: Longer-storage red blood cell units
Red blood cell units stored >= 21 days
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991341

  Show 33 Study Locations
Sponsors and Collaborators
New England Research Institutes
Investigators
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
  More Information

No publications provided by New England Research Institutes

Additional 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, HL072268, HL072033, HL072291, HL072196, HL072289, HL072248, HL072191, HL072299, HL072305, HL072274, HL072028, HL072359, HL072072, HL072355, HL072283, HL072346, HL072331, HL072290
Study First Received: October 7, 2009
Last Updated: May 27, 2014
Health Authority: United States: Federal Government

Keywords provided by New England Research Institutes:
Cardiac surgery
Red blood cell
Transfusion

ClinicalTrials.gov processed this record on September 29, 2014