Return to Results

Mechanism and Repository Study for the Red Cell Storage Duration Study

new search

Trial Conditions
  • Cardiac Surgery
  • Erythrocyte Transfusion
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria for RECESS subjects participating in MARS:

1. Randomized in Red Cell Storage Duration Study (RECESS)

2. Patients ≥ 18 years old

Exclusion Criteria for RECESS subjects participating in MARS:

- There are no exclusion criteria.

Inclusion Criteria for healthy volunteers participating in MARS:

1. At least 18 years old

2. In generally good health

Exclusion Criteria for healthy volunteers participating in MARS:

1. History of red blood cell transfusion within the previous 6 months.

2. History of surgery within the previous 6 months.

3. Currently treated with inhaled nitric oxide, nitroglycerin in any form, or
nitroprusside.

4. Currently treated with prednisone, corticosteroids, cyclosporine, chemotherapy,
remicade, methotrexate, Enbrel and/or any antibody based therapy to modulate the
immune system.

5. Currently treated with heparin or other anticoagulants (for example coumadin,
pradaxa, and low molecular weight heparin).

6. Received any non-steroidal anti-inflammatory drug within the previous 24 hours.

7. Received aspirin within the previous 5 days.

Gender: Both
Steward Physician(s)
  • Philip Spinella, MD
  • Philip Norris, MD
  • Susan Assmann, PhD
Physician Researcher

Investigator Name:

  • Philip Spinella, MD
  • Philip Norris, MD
  • Susan Assmann, PhD

Other Information

Sponsor: New England Research Institutes
Phase: N/A
Trial ID: NCT01541319
Volunteers:  Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2014 Steward Health Care
Connect Healthcare Panacea CMS Solutions