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Status:

COMPLETED

Red Cell Storage Duration Study

Lead Sponsor:

Carelon Research

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Cardiac Surgery

Erythrocyte Transfusion

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • \>= 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

  • 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

Key Trial Info

Start Date :

January 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2014

Estimated Enrollment :

1481 Patients enrolled

Trial Details

Trial ID

NCT00991341

Start Date

January 1 2010

End Date

March 1 2014

Last Update

June 9 2015

Active Locations (33)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 9 (33 locations)

1

University of Florida

Gainesville, Florida, United States, 32610

2

Emory University

Atlanta, Georgia, United States, 30322

3

St. Joseph Hospital

Fort Wayne, Indiana, United States, 46802

4

Indiana/Ohio Heart

Fort Wayne, Indiana, United States, 46804