The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
Liberal versus restrictive transfusion
Brigham and Women's Hospital
Boston, Massachusetts, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Jack D. Weiler Hospital of Montefiore Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Hemoglobin Concentration
Differences in the mean hemoglobin concentrations between the two study arms.
Time frame: In-hospital up to 30 days post randomization
Red Blood Cell Transfusion
Differences in mean number of units of red blood cell transfusions between the two study arms.
Time frame: In-hospital up to 30 days post randomization
Mortality or Myocardial Ischemia
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: 30 days
Mortality or Myocardial Ischemia
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: 6 months
Individual Components of Composite Outcome
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
Mortality From Cardiac Causes
Time frame: 30 days
Unscheduled Hospital Admission
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Data Coordinating Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Time frame: 30 days
Stroke
Time frame: 30 days
Congestive Heart Failure
Time frame: 30 days
Stent Thrombosis
Time frame: 30 days
Deep Vein Thrombosis or Pulmonary Embolism
Time frame: 30 days
Pneumonia or Blood Stream Infection and Each Separately
Time frame: 30 days
Composite Mortality and Morbidity
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.
Time frame: 30 days