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|Summary of Trial: |
The RECESS study will compare the effects of transfusing red blood cell units stored <= 10 days versus 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.
|Principal Investigator:||Dr. Paul Ness|
Rosemary Case, RN
Kimberly Behrens, RN
|Study Long Title:|
Red Cell Storage Duration Study
|Study Short Title:||RECESS Study|
|JHU IRB Number:|
|Funding Source:||National Heart, Lung & Blood Institute|
Patients 18 years and older
Patients greater than or equal to 88 pounds
Scheduled complex cardiac surgery with planned use of median sternotomy
Patients greater than or equal to 18 years must have a Transfusion Risk Understanding Score Tool (TRUST) probability score greater than or equal to 3
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 re-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 randomized into the RECESS study
|Clinical Trial Site:|
Johns Hopkins Hospital
This is a multi-center study – there are 21 sites across the U.S. that are participating in this clinical trial.
|Anticipated End Date:||2013|
|Compensation for Participating:||None|