Brief Summary
The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.
Brief Title
Myocardial Ischemia and Transfusion
Detailed Description
In most clinical settings, evidence suggests it is safe to wait to give a blood transfusion. However, for those who have suffered a heart attack, there is a lack of high quality evidence to guide transfusions. This 3500 subject multi-center randomized trial will fill that void.
Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10 g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.
Patients randomized to the liberal transfusion strategy will receive a red blood cell transfusion anytime there is a blood count of less than 10 g/dL.
Patients randomized to the restrictive transfusion strategy are permitted to receive a blood transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered regardless of the blood count.
The transfusions strategies will be maintained until hospital discharge for a maximum of 30 days.
Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be confirmed at 180 days.
Hospital inpatients diagnosed with myocardial infarction who have blood counts less than 10 g/dL are randomized to receive either a liberal or a restrictive transfusion strategy.
Patients randomized to the liberal transfusion strategy will receive a red blood cell transfusion anytime there is a blood count of less than 10 g/dL.
Patients randomized to the restrictive transfusion strategy are permitted to receive a blood transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion is ordered regardless of the blood count.
The transfusions strategies will be maintained until hospital discharge for a maximum of 30 days.
Patients will be followed for 30 days for clinically relevant outcomes. Vital status will be confirmed at 180 days.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Myocardial Infarction
Anemia
Eligibility Criteria
Inclusion Criteria:
* 18 years of age or older
* Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
* Hemoglobin concentration less than 10 g/dL at the time of random allocation
* Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Exclusion Criteria:
* Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
* Decline blood transfusion
* Scheduled for cardiac surgery during the current admission
* Receiving only palliative treatment
* Known that follow-up will not be possible at 30 days
* Previously participated in MINT
* Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
* Patient physician does not believe the patient is an appropriate candidate for the trial
* 18 years of age or older
* Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
* Hemoglobin concentration less than 10 g/dL at the time of random allocation
* Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Exclusion Criteria:
* Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
* Decline blood transfusion
* Scheduled for cardiac surgery during the current admission
* Receiving only palliative treatment
* Known that follow-up will not be possible at 30 days
* Previously participated in MINT
* Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
* Patient physician does not believe the patient is an appropriate candidate for the trial
Inclusion Criteria
Inclusion Criteria:
* 18 years of age or older
* Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
* Hemoglobin concentration less than 10 g/dL at the time of random allocation
* Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
* 18 years of age or older
* Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
* Hemoglobin concentration less than 10 g/dL at the time of random allocation
* Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient
Gender
All
Gender Based
false
Keywords
Red Blood Cell Transfusion
Anemia
Heart Disease
Cardiovascular Disease
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02981407
Org Class
Other
Org Full Name
Rutgers, The State University of New Jersey
Org Study Id
Pro20160000722
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Myocardial Ischemia and Transfusion
Primary Outcomes
Outcome Measure
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
Outcome Time Frame
Within 30 days of randomization
Secondary Ids
Secondary Id
1U01HL133817-01
Secondary Outcomes
Outcome Time Frame
Within 30 days of randomization
Outcome Measure
All-cause Mortality
Outcome Time Frame
Within 30 days of randomization
Outcome Measure
Myocardial Reinfarction
Outcome Time Frame
Within 30 days of randomization
Outcome Measure
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mark Menegus
Investigator Email
mmenegus@montefiore.org