Coronary Artery Disease, Myocardial Infarction, Unstable Angina
Conditions
Keywords
blood transfusion, red blood cell transfusion, myocardial infarction, acute coronary syndrome, anemia
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 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.
Interventions
BIOLOGICALRed blood cell transfusion
Liberal versus restrictive transfusion
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Albert Einstein College of Medicine
Brigham and Women's Hospital
Rhode Island Hospital
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
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Concentration | In-hospital up to 30 days post randomization | Differences in the mean hemoglobin concentrations between the two study arms. |
| Red Blood Cell Transfusion | In-hospital up to 30 days post randomization | Differences in mean number of units of red blood cell transfusions between the two study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality From Cardiac Causes | 30 days | — |
| Unscheduled Hospital Admission | 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. |
| Stroke | 30 days | — |
| Congestive Heart Failure | 30 days | — |
| Mortality or Myocardial Ischemia | 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. |
| Deep Vein Thrombosis or Pulmonary Embolism | 30 days | — |
| Pneumonia or Blood Stream Infection and Each Separately | 30 days | — |
| Composite Mortality and Morbidity | 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. |
| Stent Thrombosis | 30 days | — |
| Individual Components of Composite Outcome | 30 days | All cause mortality Myocardial infarction (recurrent if had ST segment or Non ST segment MI or new myocardial infarction) Unscheduled coronary revascularization. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liberal Transfusion Strategy Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood 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. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL. | 55 |
| Restrictive Transfusion Strategy Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.
Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension. | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Liberal Transfusion Strategy | Restrictive Transfusion Strategy | Total |
|---|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 13.6 | 74.3 years STANDARD_DEVIATION 11.1 | 70.8 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 27 Participants | 28 Participants | 55 Participants |
| Sex: Female, Male Male | 28 Participants | 27 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 7 / 55 | 10 / 54 |
Outcome results
Primary
Hemoglobin Concentration
Differences in the mean hemoglobin concentrations between the two study arms.
Time frame: In-hospital up to 30 days post randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liberal Transfusion Strategy | Hemoglobin Concentration | Hemoglobin Day 1 Post Randomization | 10.30 g/dL | Standard Deviation 1 |
| Liberal Transfusion Strategy | Hemoglobin Concentration | Hemoglobin Day 2 Post Randomization | 10.78 g/dL | Standard Deviation 0.78 |
| Liberal Transfusion Strategy | Hemoglobin Concentration | Hemoglobin Day 3 Post Randomization | 10.64 g/dL | Standard Deviation 0.71 |
| Restrictive Transfusion Strategy | Hemoglobin Concentration | Hemoglobin Day 1 Post Randomization | 9.03 g/dL | Standard Deviation 0.82 |
| Restrictive Transfusion Strategy | Hemoglobin Concentration | Hemoglobin Day 2 Post Randomization | 8.98 g/dL | Standard Deviation 0.8 |
| Restrictive Transfusion Strategy | Hemoglobin Concentration | Hemoglobin Day 3 Post Randomization | 9.12 g/dL | Standard Deviation 0.75 |
Comparison: Day 1 Post Randomizationp-value: <0.001t-test, 2 sided
Comparison: Day 2 Post Randomizationp-value: <0.001t-test, 2 sided
Comparison: Day 3 Post Randomizationp-value: <0.001t-test, 2 sided
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liberal Transfusion Strategy | Red Blood Cell Transfusion | 1.58 blood units | Standard Deviation 1.13 |
| Restrictive Transfusion Strategy | Red Blood Cell Transfusion | 0.49 blood units | Standard Deviation 1.03 |
p-value: <0.001t-test, 2 sided
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Composite Mortality and Morbidity | 6 Participants |
| Restrictive Transfusion Strategy | Composite Mortality and Morbidity | 16 Participants |
Secondary
Congestive Heart Failure
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Congestive Heart Failure | 2 Participants |
| Restrictive Transfusion Strategy | Congestive Heart Failure | 7 Participants |
Secondary
Deep Vein Thrombosis or Pulmonary Embolism
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Deep Vein Thrombosis or Pulmonary Embolism | 1 Participants |
| Restrictive Transfusion Strategy | Deep Vein Thrombosis or Pulmonary Embolism | 0 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liberal Transfusion Strategy | Individual Components of Composite Outcome | Mortality | 1 Participants |
| Liberal Transfusion Strategy | Individual Components of Composite Outcome | Myocardial Infarction | 5 Participants |
| Liberal Transfusion Strategy | Individual Components of Composite Outcome | Unscheduled Coronary Revascularization | 0 Participants |
| Restrictive Transfusion Strategy | Individual Components of Composite Outcome | Mortality | 7 Participants |
| Restrictive Transfusion Strategy | Individual Components of Composite Outcome | Myocardial Infarction | 7 Participants |
| Restrictive Transfusion Strategy | Individual Components of Composite Outcome | Unscheduled Coronary Revascularization | 2 Participants |
Comparison: Mortality95% CI: [0.91, 56.02]
Comparison: Myocardial Infarction95% CI: [0.48, 4.22]
Secondary
Mortality From Cardiac Causes
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Mortality From Cardiac Causes | 1 Participants |
| Restrictive Transfusion Strategy | Mortality From Cardiac Causes | 7 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Mortality or Myocardial Ischemia | 15 Participants |
| Restrictive Transfusion Strategy | Mortality or Myocardial Ischemia | 20 Participants |
95% CI: [-5.3, 24.7]
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Mortality or Myocardial Ischemia | 6 Participants |
| Restrictive Transfusion Strategy | Mortality or Myocardial Ischemia | 14 Participants |
95% CI: [0.99, 5.73]
Secondary
Pneumonia or Blood Stream Infection and Each Separately
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liberal Transfusion Strategy | Pneumonia or Blood Stream Infection and Each Separately | Blood Stream Infection | 0 Participants |
| Liberal Transfusion Strategy | Pneumonia or Blood Stream Infection and Each Separately | Pneumonia or Blood Stream Infection | 0 Participants |
| Liberal Transfusion Strategy | Pneumonia or Blood Stream Infection and Each Separately | Pneumonia | 0 Participants |
| Restrictive Transfusion Strategy | Pneumonia or Blood Stream Infection and Each Separately | Pneumonia or Blood Stream Infection | 2 Participants |
| Restrictive Transfusion Strategy | Pneumonia or Blood Stream Infection and Each Separately | Pneumonia | 2 Participants |
| Restrictive Transfusion Strategy | Pneumonia or Blood Stream Infection and Each Separately | Blood Stream Infection | 0 Participants |
Secondary
Stent Thrombosis
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Stent Thrombosis | 0 Participants |
| Restrictive Transfusion Strategy | Stent Thrombosis | 0 Participants |
Secondary
Stroke
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Liberal Transfusion Strategy | Stroke | 1 Participants |
| Restrictive Transfusion Strategy | Stroke | 0 Participants |
Secondary
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.
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liberal Transfusion Strategy | Unscheduled Hospital Admission | Any Readmission | 9 Participants |
| Liberal Transfusion Strategy | Unscheduled Hospital Admission | Cardiac Readmission | 3 Participants |
| Liberal Transfusion Strategy | Unscheduled Hospital Admission | Infection Readmission | 0 Participants |
| Restrictive Transfusion Strategy | Unscheduled Hospital Admission | Any Readmission | 17 Participants |
| Restrictive Transfusion Strategy | Unscheduled Hospital Admission | Cardiac Readmission | 8 Participants |
| Restrictive Transfusion Strategy | Unscheduled Hospital Admission | Infection Readmission | 2 Participants |