Red Cell Storage Duration Study

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

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Carelon Research

  lead OTHER

Principal Investigators

• Susan F Assmann, PhD · Carelon Research

• Steven Sloan, MD · Boston Children's Hospital

• Thomas Ortel, MD · Duke University

• Cassandra Josephson, MD · Emory University

• Christopher Stowell, MD · Massachusetts General Hospital

• Meghan Delaney, DO · University of Washington/Fred Hutchinson Cancer Research Center

• Marie Steiner, MD · University of Minnesota Medical Center Fairview

• Darrell Triulzi, MD · University of Pittsburgh Presbyterian and Shadyside

• Lynne Uhl, MD · Beth Israel Deaconess Medical Center

• Richard Kaufman, MD · Brigham and Women's Hospital

• James Bussel, MD · Weill Medical College of Cornell University

• Paul Ness, MD · Johns Hopkins University

• Thomas Raife, MD · University of Iowa

• Rhonda Cooke, MD · University of Maryland

• Nigel Key, MD · University of North Carolina, Chapel Hill

• Jeff Carson, MD · Rutgers, The State University of New Jersey

• Vincent Scavo, MD · Indiana/Ohio Heart

• Wade Fischer, MD, FACS · Froedtert Hospital

• Pampee Young, MD · Vanderbilt University

• Kathy Puca, MD · St. Luke's Hospital

• James George, MD · University of Oklahoma

• Gregory Nuttall, MD · Mayo Clinic

• Arthur Bracey, MD · Texas Heart Institute

• Richard Engleman, MD · Baystate Medical Center

• Philip Greileich, MD · University of Texas

• Kent Berg, MD · University of Florida

• Robert Hunsaker, MD · St. Elizabeth's Medical Center

• Ronald Miles, MD · Aspirus Medical Center

• Ravindra Karanam, MD · Barnabas Health, Newark Beth Israel Medical Center

• Cornelius Dyke, MD · Sanford Heart Center

• Eldad Hod, MD · Columbia University Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States

Study Locations