Status:
COMPLETED
Myocardial Ischemia and Transfusion Pilot
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Conditions:
Myocardial Infarction
Unstable Angina
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.
Detailed Description
Red blood cell transfusions are extremely common medical interventions, yet, it remains unclear when patients should be transfused. This pilot study will evaluate the feasibility of conducting a resea...
Eligibility Criteria
Inclusion
- age 18 or older;
- STEMI (ST segment elevated myocardial infarction)
- NSTEMI (Non ST segment elevation myocardial infarction)
- unstable angina
- stable coronary artery disease (undergoing cardiac catheterization during the index hospitalization);
- written informed consent has been obtained
- hemoglobin concentration less than 10 g/dL at the time of random allocation.
Exclusion
- bleeding cannot be controlled at the cardiac catheterization puncture site and/or require surgery to repair vessel
- retroperitoneal bleeding requiring surgery
- clinically important hemodynamic instability based on the judgment of the treating physician
- terminal malignancy or life expectancy less than 6 months
- scheduled for cardiac surgery within the next 30 days
- symptomatic at the time of randomization
- declines blood transfusion
- history of a clinically significant transfusion reaction
- inability to provide informed consent;
- enrolled in a competing study
- previous participation in the MINT trial
- any patient who in the judgment of the research team should not be enrolled in the trial. This would include, but not be limited to, factors such alcohol or drug dependence, or psychiatric illness.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01167582
Start Date
September 1 2009
End Date
June 1 2012
Last Update
March 20 2019
Active Locations (7)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
2
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
3
Jack D. Weiler Hospital of Montefiore Medical Center
New York, New York, United States, 10461
4
Montefiore Medical Center
The Bronx, New York, United States, 10461-2301