Mechanism and Repository Study for the Red Cell Storage Duration Study

NCT01541319 | Completed DMC

• 2 other identifiers: 7123U01HL072268-09S1
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 13

Brief Summary

A large multicenter randomized controlled trial of approximately 1700 critically ill patients' status post complex cardiac surgery with sternotomy, called the Red Cell Storage Duration Study (RECESS), is currently ongoing. In the RECESS trial, study groups are randomized to either RBCs of less than or equal to 10 days storage time or to greater than or equal to 21 days. The primary outcome of RECESS is a change in multiple organ dysfunction score. Secondary outcomes in RECESS include all cause 28-day mortality, mechanical ventilation free days, and other clinical outcomes. The RECESS study presents a unique opportunity to investigate mechanisms associated with RBC storage duration in the context of clinical outcomes for well-characterized surgical study groups. The ancillary study described here is called the Mechanism and Repository Study (MARS) for RECESS. The MARS study will analyze the most commonly reported and hypothesized mechanisms considered to be associated with the RBC storage lesion and adverse outcomes in critically ill patients. Laboratories with expertise in RBC function, nitric oxide mechanisms, the coagulation cascade, microparticle analysis and immunology will each examine hypotheses addressing mechanisms potentially able to relate storage time to clinical outcomes in RBC transfusion recipients. At the conclusion of the study, the results will provide a much better understanding of how RBC storage age affects recipient RBC function, coagulation parameters, microparticle load and immune modulation. Perhaps most importantly, this study will also develop a large sample repository for future analysis.

Conditions

Cardiac Surgery; Erythrocyte Transfusion

Keywords

Cardiac Surgery; Erythrocyte Transfusion

Outcome Measures

Primary Outcomes (1)

• Comparison of pre- and post-operative lab values of vascular signaling, coagulation, microparticle counts, and inflammation and immune function

  The primary objective of MARS is to compare post-operative values of these laboratory parameters between RBC-transfused RECESS subjects randomized to receive RBCs stored 10 days or less and RBC-transfused RECESS subjects randomized to receive RBCs stored 21 days or more.

  Day 2, 6, 28 and 180

Study Arms (4)

Randomized to <= 10day RBCs & transfused

Subjects in the RECESS study who were randomized to receive red blood cell (RBC) units stored no more than 10 days, and who received at least one RBC transfusion between randomization and 96 hours after the cardiac surgery ends

Randomized to >= 21day RBCs & transfused

Subjects in the RECESS study who were randomized to receive red blood cell (RBC) units stored at least 21 days, and who received at least one RBC transfusion between randomization and 96 hours after the cardiac surgery ends

Randomized but not transfused

Subjects randomized in the RECESS study who did not receive any red blood cell units between randomization and 96 hours after the end of surgery

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are two study populations for MARS. One study population is adult subjects undergoing complex cardiac surgery who are participating in the RECESS trial. The other study population is a set of healthy adult volunteers.

You may qualify if:

• Randomized in Red Cell Storage Duration Study (RECESS)
• Patients ≥ 18 years old

You may not qualify if:

• At least 18 years old
• In generally good health
• History of red blood cell transfusion within the previous 6 months.
• History of surgery within the previous 6 months.
• Currently treated with inhaled nitric oxide, nitroglycerin in any form, or nitroprusside.
• Currently treated with prednisone, corticosteroids, cyclosporine, chemotherapy, remicade, methotrexate, Enbrel and/or any antibody based therapy to modulate the immune system.
• Currently treated with heparin or other anticoagulants (for example coumadin, pradaxa, and low molecular weight heparin).
• Received any non-steroidal anti-inflammatory drug within the previous 24 hours.
• Received aspirin within the previous 5 days.

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (13)

Blood Systems Research Institute

San Francisco, California, 94118, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Indiana/Ohio Heart

Fort Wayne, Indiana, 46804, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

University of Minnesota - Fairview

Minneapolis, Minnesota, 55455, United States

Location

Robert Wood Johnson Medial School

New Brunswick, New Jersey, 08903, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Texas Heart Institute

Houston, Texas, 77225, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Froedtert Memorial Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Aspirus Heart & Vascular Institute

Wausau, Wisconsin, 54401, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, pRBCs, PBMCs

Study Officials

• Philip Spinella, MD

  Washington University School of Medicine

  STUDY CHAIR

• Philip Norris, MD

  Vitalant Research Institute

  STUDY CHAIR

• Susan Assmann, PhD

  Carelon Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 29, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

US (13)