Myocardial Ischemia and Transfusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,506
- 试验地点
- 211
- 主要终点
- Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction
时间窗: Within 30 days of randomization
次要结局
- Myocardial Reinfarction(Within 30 days of randomization)
- All-cause Mortality(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)
研究者
Jeffrey L Carson, MD
Principal Investigator
Rutgers, The State University of New Jersey