NCT00991341

Red Cell Storage Duration Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,481 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cardiac Surgery
• Erythrocyte Transfusion

Interventions

Type	Name	Description
BIOLOGICAL	Red blood cell units stored <= 10 days	Pre-storage leukoreduced red blood cell units stored \<=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
BIOLOGICAL	Red blood cell units stored >= 21 days	Pre-storage leukoreduced red blood cell units stored \>=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2009-10-08
• Last updated: 2015-06-09
• Results posted: 2015-06-09

Locations

33 sites across 1 country: United States