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Completed No phase listed Observational Accepts healthy volunteers

Mechanism and Repository Study for the Red Cell Storage Duration Study

ClinicalTrials.gov ID: NCT01541319

Public ClinicalTrials.gov record NCT01541319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 12:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01541319
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Carelon Research
Other
Enrollment
92 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2012
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016
Last update posted
Sep 7, 2016

2012 – 2016

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Blood Systems Research Institute San Francisco California 94118
Emory University Atlanta Georgia 30322
Indiana/Ohio Heart Fort Wayne Indiana 46804
University of Iowa Iowa City Iowa 52242
St. Elizabeth's Medical Center Boston Massachusetts 02135
University of Minnesota - Fairview Minneapolis Minnesota 55455
Robert Wood Johnson Medial School New Brunswick New Jersey 08903
Vanderbilt University Nashville Tennessee 37232
University of Texas Southwestern Dallas Texas 75390
Texas Heart Institute Houston Texas 77225
Aurora St. Luke's Medical Center Milwaukee Wisconsin 53215
Froedtert Memorial Hospital Milwaukee Wisconsin 53226
Aspirus Heart & Vascular Institute Wausau Wisconsin 54401

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01541319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2016 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01541319 live on ClinicalTrials.gov.

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