Anemia, Myocardial Infarction
Conditions
Keywords
Red Blood Cell Transfusion, Anemia, Heart Disease, Cardiovascular Disease
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.
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.
Interventions
BIOLOGICALRed Blood Cell Transfusion
Transfusion of packed red blood cell units
Sponsors
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction | Within 30 days of randomization |
Secondary
| Measure | Time frame |
|---|---|
| All-cause Mortality | Within 30 days of randomization |
| Myocardial Reinfarction | Within 30 days of randomization |
| Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis | Within 30 days of randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Unscheduled Readmission to Hospital for Any Reason | Within 30 days of randomization | — |
| Stroke | Within 30 days of randomization | — |
| Pulmonary Embolism or Deep Venous Thrombosis | Within 30 days of randomization | — |
| Bleed | Within 30 days of randomization | — |
| Pneumonia | Within 30 days of randomization | — |
| Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina | Within 30 days of randomization | — |
| Urinary Tract Infection | Within 30 days of randomization | — |
| Length of Hospital Stay Post Randomization | Within 30 days of randomization | — |
| Number of Days Post Randomization in Intensive Care Unit | Within 30 days of randomization | — |
| Patient Reported Quality of Life | Within 30 days of randomization | EuroQol questionnaire |
| All-cause Mortality | Within 6 months of randomization | — |
| Blood Stream Infection | Within 30 days of randomization | — |
| Ischemia Driven Unscheduled Coronary Revascularization | Within 30 days of randomization | — |
| Unscheduled Readmission to Hospital for Ischemic Cardiac Diagnosis | Within 30 days of randomization | — |
| Heart Failure | Within 30 days of randomization | — |
Countries
Australia, Brazil, Canada, France, New Zealand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liberal Transfusion Strategy Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days.
Red Blood Cell Transfusion: Transfusion of packed red blood cell units | 1,755 |
| Restrictive Transfusion Strategy Permitted to receive a red blood cell 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 will be ordered regardless of the blood count.
Red Blood Cell Transfusion: Transfusion of packed red blood cell units | 1,749 |
| Total | 3,504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Liberal Transfusion Strategy | Restrictive Transfusion Strategy | Total |
|---|---|---|---|
| Age, Continuous | 72.1 years STANDARD_DEVIATION 11.6 | 72.2 years STANDARD_DEVIATION 11.5 | 72.1 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 134 Participants | 119 Participants | 253 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1434 Participants | 1445 Participants | 2879 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 187 Participants | 185 Participants | 372 Participants |
| History of Coronary Artery Bypass Surgery No | 1365 Participants | 1377 Participants | 2742 Participants |
| History of Coronary Artery Bypass Surgery Yes | 390 Participants | 372 Participants | 762 Participants |
| History of Heart Failure No | 1216 Participants | 1222 Participants | 2438 Participants |
| History of Heart Failure Yes | 539 Participants | 527 Participants | 1066 Participants |
| History of Myocardial Infarction No | 1206 Participants | 1160 Participants | 2366 Participants |
| History of Myocardial Infarction Yes | 549 Participants | 589 Participants | 1138 Participants |
| History of Percuatneous Coronary Intervention No | 1177 Participants | 1126 Participants | 2303 Participants |
| History of Percuatneous Coronary Intervention Unknown | 1 Participants | 0 Participants | 1 Participants |
| History of Percuatneous Coronary Intervention Yes | 577 Participants | 623 Participants | 1200 Participants |
| Race/Ethnicity, Customized Black | 223 Participants | 217 Participants | 440 Participants |
| Race/Ethnicity, Customized Other | 115 Participants | 129 Participants | 244 Participants |
| Race/Ethnicity, Customized Unknown | 172 Participants | 174 Participants | 346 Participants |
| Race/Ethnicity, Customized White | 1245 Participants | 1229 Participants | 2474 Participants |
| Sex: Female, Male Female | 819 Participants | 774 Participants | 1593 Participants |
| Sex: Female, Male Male | 936 Participants | 975 Participants | 1911 Participants |
| ST or Non-ST-Elevation Myocardial Infarction NSTEMI | 1418 Participants | 1430 Participants | 2848 Participants |
| ST or Non-ST-Elevation Myocardial Infarction STEMI | 337 Participants | 319 Participants | 656 Participants |
| Type of Myocardial Infarction Other or Unknown | 37 Participants | 52 Participants | 89 Participants |
| Type of Myocardial Infarction Type 1 | 730 Participants | 730 Participants | 1460 Participants |
| Type of Myocardial Infarction Type 2 | 988 Participants | 967 Participants | 1955 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 353 / 1,755 | 376 / 1,749 |
| other Total, other adverse events | 330 / 1,755 | 348 / 1,749 |
| serious Total, serious adverse events | 699 / 1,755 | 723 / 1,749 |
Outcome results
Primary
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction | 255 Participants |
| Restrictive Transfusion Strategy | Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction | 295 Participants |
Secondary
All-cause Mortality
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | All-cause Mortality | 146 Participants |
| Restrictive Transfusion Strategy | All-cause Mortality | 173 Participants |
Secondary
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis | 305 Participants |
| Restrictive Transfusion Strategy | Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis | 342 Participants |
Secondary
Myocardial Reinfarction
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Myocardial Reinfarction | 126 Participants |
| Restrictive Transfusion Strategy | Myocardial Reinfarction | 149 Participants |
Other Pre-specified
All-cause Mortality
Time frame: Within 6 months of randomization
Other Pre-specified
Bleed
Time frame: Within 30 days of randomization
Other Pre-specified
Blood Stream Infection
Time frame: Within 30 days of randomization
Other Pre-specified
Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina | 300 Participants |
| Restrictive Transfusion Strategy | Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina | 338 Participants |
Other Pre-specified
Heart Failure
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Heart Failure | 111 Participants |
| Restrictive Transfusion Strategy | Heart Failure | 102 Participants |
Other Pre-specified
Ischemia Driven Unscheduled Coronary Revascularization
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Ischemia Driven Unscheduled Coronary Revascularization | 39 Participants |
| Restrictive Transfusion Strategy | Ischemia Driven Unscheduled Coronary Revascularization | 43 Participants |
Other Pre-specified
Length of Hospital Stay Post Randomization
Time frame: Within 30 days of randomization
Other Pre-specified
Number of Days Post Randomization in Intensive Care Unit
Time frame: Within 30 days of randomization
Other Pre-specified
Patient Reported Quality of Life
EuroQol questionnaire
Time frame: Within 30 days of randomization
Other Pre-specified
Pneumonia
Time frame: Within 30 days of randomization
Other Pre-specified
Pulmonary Embolism or Deep Venous Thrombosis
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Pulmonary Embolism or Deep Venous Thrombosis | 34 Participants |
| Restrictive Transfusion Strategy | Pulmonary Embolism or Deep Venous Thrombosis | 26 Participants |
Other Pre-specified
Stroke
Time frame: Within 30 days of randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Stroke | 26 Participants |
| Restrictive Transfusion Strategy | Stroke | 30 Participants |
Other Pre-specified
Unscheduled Readmission to Hospital for Any Reason
Time frame: Within 30 days of randomization
Other Pre-specified
Unscheduled Readmission to Hospital for Ischemic Cardiac Diagnosis
Time frame: Within 30 days of randomization
Other Pre-specified
Urinary Tract Infection
Time frame: Within 30 days of randomization