Red Cell Storage Duration Study (RECESS)

Carelon Research

Status and phase

Completed

Phase 3

Conditions

Cardiac Surgery

Erythrocyte Transfusion

Treatments

Biological: Red blood cell units stored <= 10 days

Biological: Red blood cell units stored >= 21 days

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00991341

HL072331

HL072196

HL072283

HL072274

HL072299

HL072355

HL072359

HL072191

HL072028

HL072248

HL072268

HL072305

HL072289

676

HL072072

U01HL072268 (U.S. NIH Grant/Contract)

HL072290

HL072346

HL072291

HL072033

Details and patient eligibility

About

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.

Enrollment

1,481 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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