Myocardial Ischemia and Transfusion Pilot
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 13
- 主要终点
- Hemoglobin Concentration
研究概览
简要总结
The purpose of this study is to evaluate two approaches to red blood cell transfusion in anemic patients with acute coronary syndrome.
详细描述
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.
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
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Red blood cell transfusion (Biological)
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.
干预措施: Red blood cell transfusion (Biological)
结局指标
主要结局
Hemoglobin Concentration
时间窗: In-hospital up to 30 days post randomization
Differences in the mean hemoglobin concentrations between the two study arms.
Red Blood Cell Transfusion
时间窗: In-hospital up to 30 days post randomization
Differences in mean number of units of red blood cell transfusions between the two study arms.
次要结局
- Mortality or Myocardial Ischemia(6 months)
- Individual Components of Composite Outcome(30 days)
- Mortality From Cardiac Causes(30 days)
- Unscheduled Hospital Admission(30 days)
- Stroke(30 days)
- Congestive Heart Failure(30 days)
- Stent Thrombosis(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)
研究者
Jeffrey L Carson, MD
Jeffrey L Carson
Rutgers, The State University of New Jersey