red blood cell transfusion
BiologicalLiberal versus restrictive transfusion
NCT Number: NCT01167582
The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Brigham and Women's Hospital, Boston, Massachusetts, United States
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 research protocol that will lead to a large scale clinical trial designed to evaluate the treatment effectiveness of two transfusion threshold strategies in patients with coronary artery disease.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Liberal versus restrictive transfusion
Time frame: In-hospital up to 30 days post randomization
Differences in the mean hemoglobin concentrations between the two study arms.
Time frame: In-hospital up to 30 days post randomization
Differences in mean number of units of red blood cell transfusions between the two study arms.
Time frame: 30 days
Composite 30 day rates of all cause 30 day mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) up to 30 days after randomization, or unscheduled coronary revascularization within 30 days.
Time frame: 6 months
Composite 6 month rates of all cause 6 month mortality, recurrent myocardial infarction up to 6 months after randomization, unscheduled coronary revascularization within 6 months.
Time frame: 30 days
All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization.
Time frame: 30 days
Time frame: 30 days
Unscheduled hospital admission at 30 days for any reason, for cardiac reason (e.g., acute coronary syndrome, MI, congestive heart failure, or arrhythmia), or infection.
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Composite rates of all cause mortality, or myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction), or unscheduled coronary revascularization or pneumonia.
Rutgers, The State University of New Jersey
Other
Acronym: MINT Pilot
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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