Cardiac Surgery Clinical Trial
— MARSOfficial title:
Mechanism and Repository Study for the Red Cell Storage Duration Study
Verified date | September 2016 |
Source | New England Research Institutes |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | St. Elizabeth's Medical Center | Boston | Massachusetts |
United States | University of Texas Southwestern | Dallas | Texas |
United States | Indiana/Ohio Heart | Fort Wayne | Indiana |
United States | Texas Heart Institute | Houston | Texas |
United States | University of Iowa | Iowa City | Iowa |
United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Froedtert Memorial Hospital | Milwaukee | Wisconsin |
United States | University of Minnesota - Fairview | Minneapolis | Minnesota |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Robert Wood Johnson Medial School | New Brunswick | New Jersey |
United States | Blood Systems Research Institute | San Francisco | California |
United States | Aspirus Heart & Vascular Institute | Wausau | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
New England Research Institutes | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04051021 -
Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
|
N/A | |
Recruiting |
NCT04604886 -
The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
|
N/A | |
Recruiting |
NCT04075981 -
Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)
|
Phase 3 | |
Completed |
NCT04062396 -
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
|
N/A | |
Recruiting |
NCT04709705 -
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT05563662 -
SURgical Registry of ENDocarditis EuRope
|
||
Withdrawn |
NCT03289104 -
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
|
N/A | |
Completed |
NCT04199039 -
Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction
|
N/A | |
Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
Completed |
NCT02964026 -
Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients
|
N/A | |
Completed |
NCT02471001 -
The Levels of Anaesthetics in Heart Muscle During Heart Surgery
|
N/A | |
Completed |
NCT02325726 -
RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.
|
N/A | |
Completed |
NCT01246947 -
Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation
|
N/A | |
Completed |
NCT01151254 -
Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
|
N/A | |
Completed |
NCT00821262 -
Sevoflurane in Cardiac Surgery
|
Phase 4 | |
Completed |
NCT00996099 -
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
|
N/A | |
Completed |
NCT00617955 -
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
|
N/A | |
Completed |
NCT00336466 -
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)
|
Phase 2 | |
Completed |
NCT00337805 -
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
|
Phase 2/Phase 3 |