Mechanism and Repository Study for the Red Cell Storage Duration Study
Completed
Conditions studied: Cardiac Surgery, Erythrocyte Transfusion
In brief
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.
Key facts
- Study ID
- NCT01541319
- Run by
- Carelon Research
- People needed
- 92
- Starts
- 2012-07-01
- Expected to finish
- 2016-08-01
- Last updated by the study team
- 2016-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Blood Systems Research Institute — San Francisco, California, United States
- Emory University — Atlanta, Georgia, United States
- Indiana/Ohio Heart — Fort Wayne, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- St. Elizabeth's Medical Center — Boston, Massachusetts, United States
- University of Minnesota - Fairview — Minneapolis, Minnesota, United States
- Robert Wood Johnson Medial School — New Brunswick, New Jersey, United States
- Vanderbilt University — Nashville, Tennessee, United States
- University of Texas Southwestern — Dallas, Texas, United States
- Texas Heart Institute — Houston, Texas, United States
- Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
- Froedtert Memorial Hospital — Milwaukee, Wisconsin, United States
- Aspirus Heart & Vascular Institute — Wausau, Wisconsin, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.