Red Cell Storage Duration Study
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 5/5/2014 |
Start Date: | January 2010 |
End Date: | May 2014 |
Contact: | Susan F Assmann, PhD |
Email: | sassmann@neriscience.com |
Phone: | 617-972-3048 |
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.
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.
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
We found this trial at
34
sites
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Children's Hospital - Boston Boston Children's Hospital is a 395-bed comprehensive center for pediatric health...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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Minneapolis, Minnesota 55455
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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