Red Cell Storage Duration Study
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?
- >= 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
- 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