Red Cell Storage Duration Study

Completed · Phase 3

Conditions studied: Cardiac Surgery, Erythrocyte Transfusion

In brief

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.

Key facts

Study ID

NCT00991341

Run by

Carelon Research

People needed

1481

Starts

2010-01-01

Expected to finish

2014-03-01

Last updated by the study team

2015-06-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >= 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

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• St. Joseph Hospital — Fort Wayne, Indiana, United States
• Indiana/Ohio Heart — Fort Wayne, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Fairview Southdale Hospital/University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• Newark Beth Israel Deaconess Medical Center — Newark, New Jersey, United States
• Columbia University Health Center — New York, New York, United States
• Weill Cornell Medical School — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Sanford Heart Center — Fargo, North Dakota, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• University of Pittsburgh Presbyterian and Shadyside — Pittsburgh, Pennsylvania, United States
• UPMC-Mercy Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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