Red Cell Storage Duration Study (RECESS)

This study is currently recruiting participants.
Verified January 2014 by New England Research Institutes
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00991341
First received: October 7, 2009
Last updated: January 2, 2014
Last verified: January 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 ]

Estimated Enrollment: 1696
Study Start Date: January 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991341

Contacts
Contact: Susan F Assmann, PhD 617-972-3048 sassmann@neriscience.com
Contact: Julie Miller, MPH 617-972-3197 jmiller@neriscience.com

  Show 34 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: January 2, 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 April 23, 2014