Red Cell Storage Duration Study - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00991341

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 III

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:

MedlinePlus related topics: Blood Transfusion and Donation Heart Surgery

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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:	1832
Study Start Date:	January 2010
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (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
Known red blood cell antibodies requiring antigen negative units
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 22 Study Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

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:	Jerrold Levy, 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:	Peter Rock, MD	University of Maryland
Principal Investigator:	Nigel Key, MD	University of North Carolina, Chapel Hill
Principal Investigator:	Jeff Carson, MD	University of Medicine and Dentistry New Jersey
Principal Investigator:	Vincent Scavo, MD	Indiana/Ohio Heart
Principal Investigator:	Saqib Masroor, MD,MHS,FACC	Froedtert Memorial Lutheran Hospital

More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Steiner ME, Assmann SF, Levy JH, Marshall J, Pulkrabek S, Sloan SR, Triulzi D, Stowell CP. Addressing the question of the effect of RBC storage on clinical outcomes: the Red Cell Storage Duration Study (RECESS) (Section 7). Transfus Apher Sci. 2010 Aug;43(1):107-16. Epub 2010 Jul 23.

Responsible Party:	Susan F. Assmann, New England Research Institutes
ClinicalTrials.gov Identifier:	NCT00991341 History of Changes
Other Study ID Numbers:	676, 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 3, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Cardiac surgery
Red blood cell
Transfusion

ClinicalTrials.gov processed this record on February 08, 2012