Myocardial Ischemia and Transfusion (MINT) - DCC

项目总结 从临床试验中积累的证据表明，限制性输血策略在大多数临床上是安全的。 设置。然而，中度贫血引起的低携氧能力可能对患有以下疾病的患者有害 心脏缺血。急性症状性冠状动脉病变患者贫血的潜在危害 疾病得到了病理生理学数据的支持，即保持较高的血红蛋白水平可能有利于 通过增加氧气供应而导致心脏缺血。此外，110名患者薄荷试验的结果发现 在自由输血策略下，30天内全因死亡率较低，1名患者(1.8%)， 与限制性输血策略相比，7例患者(13.0%)，(p=0.032)。临床的系统评价 评估已知缺血性心脏病患者的输血策略的试验记录显示， 高质量的数据，这导致了持续的争议。缺乏高质量的证据来指导 急性心肌梗死患者的输血已在几个主要指南以及 由美国国立卫生研究院的专家小组。尽管如此，输血仍被用作衡量输血质量的负面指标 推动采用限制性战略的主要组织的关怀。产生不良后果的可能性是 真实而即时的。 在这项多中心务实试验中，我们将激活40个临床中心，并随机分配3500名患者 急性心肌梗死和血红蛋白浓度低于10g/dL的患者发生心肌缺血的风险 根据限制性或自由性输血策略进行治疗。我们的主要目标将是 确定自由输血阈值策略(10g/dL)是否更好，并将导致较低的 随机对照后30天内全部导致死亡或急性心肌梗死 采用限制性输血阈值策略(8g/dL)。我们的次要目标将检验自由主义的影响 输血策略与限制性输血策略对输血不良反应的影响 与容量超负荷、血栓形成风险和免疫力改变有关。我们将比较30天的利率 充血性心力衰竭、血栓栓塞症和肺炎。我们还将比较30天的死亡率， 心血管死亡、心肌梗死和非计划的血管重建，以及住院时间 留下来，重新住进医院。我们将在6个月后联系患者，以确定早期效果 对死亡率的影响是持续的或可能增加的。 相关性 MINT定位于确定急性心肌梗死患者输血阈值 将死亡和随后的心脏病发作降至最低。鉴于急性心肌梗塞的发病率很高， 薄荷试验的结果可以塑造临床实践。

PROJECT SUMMARY Accumulating evidence from clinical trials suggests that a restrictive transfusion strategy is safe in most clinical settings. However, a low oxygen carrying capacity from moderate anemia may be deleterious in patients with cardiac ischemia. The potential for harm associated with anemia in patients with acute symptomatic coronary disease is supported by pathophysiological data that maintaining higher hemoglobin levels could benefit the ischemic heart by increasing oxygen delivery. Furthermore, results of the 110 patient MINT pilot trial found that all-cause mortality at 30 days was less frequent with a liberal transfusion strategy, 1 patient (1.8%), compared with a restrictive transfusion strategy, 7 patients (13.0%), (p=0.032). Systematic reviews of clinical trials evaluating transfusion strategies in patients with known ischemic heart disease document the absence of high quality data which has resulted in an ongoing controversy. The lack of high quality evidence to guide transfusions in patients with acute myocardial infarction has been cited in several major guidelines as well as by an NIH expert panel. Despite this, blood transfusions are being used as a negative indicator of quality of care by major organizations driving the adoption of restrictive strategies. The potential for adverse outcomes is real and immediate. In this multicenter pragmatic trial, we will activate 40 clinical centers and will randomly allocate 3500 patients at risk of myocardial ischemia with acute myocardial infarction and hemoglobin concentration less than 10 g/dL to be treated either according to a restrictive or liberal blood transfusion strategy. Our Primary Aim will be to determine whether a liberal transfusion threshold strategy (10 g/dL) is superior and will result in lower rates of either all cause mortality or acute myocardial infarction within 30 days following randomization as compared with a restrictive transfusion threshold strategy (8 g/dL). Our secondary aims will examine the effect of a liberal transfusion strategy compared with a restrictive transfusion strategy on adverse outcomes of transfusion related to volume overload, thrombotic risk and modified immunity. We will compare 30-day rates of congestive heart failure, thromboembolism, and pneumonia. We will also compare rates of 30-day death, cardiovascular death, myocardial infarction, and unscheduled revascularization, as well as hospital length of stay, and readmission to the hospital. We will contact the patients at 6 months to determine if the early effects on mortality are sustained or possibly enhanced. Relevance MINT is positioned to determine the threshold for blood transfusions in patients with acute myocardial infarction to minimize death and subsequent heart attacks. Given the high incidence of acute myocardial infarction, the results of MINT can shape clinical practice.