Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- New or worsening heart failure
研究概览
简要总结
The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.
详细描述
The current standard of care for patients with heart attacks is to transfuse red blood cells when the hematocrit (red blood cell count) drops below 30 percent. However, there is little scientific basis for this current standard, and recent research has demonstrated that it is safe to allow the hematocrit (red blood cell count) to drop significantly lower in severely ill medical patients and in patients with heart disease undergoing major surgery. The investigators therefore propose this pilot trial to begin to determine whether or not it is safe to apply a more conservative blood transfusion strategy to patients with heart attacks.
In this study, patients who are within 72 hours of the onset of a heart attack and who are anemic (have a low red blood cell count) will be randomly assigned to one of two transfusion strategies while they are in the hospital: a liberal strategy of transfusing blood when the hematocrit falls below 30 percent (the current standard) or a conservative strategy of transfusing blood only when the hematocrit falls below 24 percent. It will then be determined which group fares better over the next 30 days.
The plan is to enroll 92 patients in this pilot trial in order to allow the researchers to plan for a much larger, definitive trial of this important question. It is anticipated that the conservative transfusion strategy will be similar to the standard (liberal) strategy in terms of patient outcomes.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of the following must be present:
- •Acute myocardial infarction with presentation within 72 hours of randomization (acute myocardial infarction is defined as ischemic-type chest discomfort lasting at least 30 minutes associated with creatinine kinase MB (CKMB) or troponin >upper limit of normal [ULN])
- •Admission to CCU
- •Hematocrit .30 or less
- •Written, informed consent
排除标准
- •Inability or unwillingness to receive red cell transfusions
- •Active bleeding (overt blood loss accompanied by a decrease in hematocrit of at least 5% in the preceding 12 hours)
- •Receipt of red cell transfusion within 7 days of randomization
- •Prior severe transfusion reaction
- •Pregnancy
- •Imminent death
- •Decision to provide limited care
- •Participation in another clinical trial in which blood transfusion is a requirement or a component of a primary or secondary endpoint
- •Previous participation in the CRIT Pilot
研究组 & 干预措施
1
Liberal transfusion threshold
干预措施: Packed Red Blood Cell Transfusion (Procedure)
2
Conservative transfusion threshold
干预措施: Packed Red Blood Cell Transfusion (Procedure)
结局指标
主要结局
New or worsening heart failure
时间窗: In-hospital
In-hospital death
时间窗: In-hospital
Recurrent myocardial infarction (MI)
时间窗: In-hospital
次要结局
- Number of transfusions received per patient(In-hospital)
- Death or recurrent MI or new or worsening congestive heart failure (CHF) at 30 days(30 days)
- Proportion of patients receiving at least one transfusion(In-hospital)
- Critical Care Unit (CCU) length of stay(In-hospital)
- Death at 30 days(30 days)
- In-hospital recurrent ischemia(In-hospital)
- Transfusion-related reactions(In-hospital)
- Length of hospitalization(In-hospital)
- Death or recurrent MI at hospital discharge and 30 days(30 days)
- In-hospital death or recurrent MI or new or worsening CHF or recurrent ischemia(In-hospital)
- Acute renal insufficiency (increase in serum creatinine of ≥ 0.5mg/dL)(In-hospitall)
- Mean daily hematocrit(In-hospital)