Mechanism and Repository Study for the Red Cell Storage Duration Study
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.
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
- Enrollment
- 92 participants
Conditions and interventions
Conditions
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
- Jul 2012 (Type not available)
- Primary completion
- Aug 2016 (Actual)
- Completion
- Aug 2016 (Actual)
- Last update posted
- Sep 8, 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 8, 2016 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01541319 live on ClinicalTrials.gov.