Red Cell Storage Duration Study

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:
1/2/2014
NCT ID:
NCT00991341