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Red Cell Storage Duration Study (RECESS)

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
Study Coordinator:

Rosemary Case, RN
Email: casero@jhmi.edu
(410) 502-2075

or

Kimberly Behrens, RN
Email: kbehren1@jhmi.edu
(410) 502-1914

Study Long Title: 

Red Cell Storage Duration Study

Study Short Title: RECESS Study
JHU IRB Number:

NA_00035493

Funding Source:National Heart, Lung & Blood Institute

Inclusions: 

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

Exclusions: 

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
600 North Wolfe Street
Baltimore, MD 21287-4618

This is a multi-center study – there are 21 sites across the U.S. that are participating in this clinical trial.

Start Date:2010
Anticipated End Date: 2013
Compensation for Participating:  None












































 

 

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