Myocardial Ischemia and Transfusion (MINT) - DCC

心肌缺血和输血 (MINT) - DCC

• 批准号: 10290738
• 负责人: Maria Mori Brooks
• 金额: $ 75.05万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10290738
• 关键词: Acute; Acute myocardial infarction; Address; Adoption; Adverse event; Anemia; Automobile Driving; Blood Transfusion; Canada; Cardiovascular system; Carrying Capacities; Cessation of life; Classification; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Data Monitoring Committees; Communities; Congestive Heart Failure; Coronary heart disease; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Reporting; Data Set; Databases; Drops; Electrocardiogram; Ensure; Event; Exclusion Criteria; Guidelines; Hemoglobin; Hemoglobin concentration result; Hospitals; Human Resources; Immunity; Incidence; Infrastructure; Intention; Intervention; Leadership; Length of Stay; Manuals; Manuscripts; Measures; Mediator of activation protein; Medical; Methods; Monitor; Myocardial Infarction; Myocardial Ischemia; National Heart, Lung, and Blood Institute; Outcome; Oxygen; Patient-Focused Outcomes; Patients; Pilot Projects; Pneumonia; Positioning Attribute; Preparation; Procedures; Process; Protocols documentation; Quality Control; Quality Indicator; Quality of Care; Randomized; Randomized Clinical Trials; Recurrence; Reporting; Risk; Scheme; Shapes; Site; Specific qualifier value; Statistical Data Interpretation; System; Thromboembolism; Training; Transfusion; Treatment Effectiveness; Uncertainty; United States; United States National Institutes of Health; Universities; Variant; Wood material; Writing; adverse outcome; base; clinical center; clinical practice; clinical research site; data centers; data management; data quality; data resource; design; epidemiologic data; experience; high risk; hospital readmission; inclusion criteria; medical schools; mortality; mortality risk; operation; patient population; pilot trial; pragmatic trial; systematic review; thrombotic; treatment strategy; user-friendly; Acute; Acute myocardial infarction; Address; Adoption; Adverse event; Anemia; Automobile Driving; Blood Transfusion; Canada; Cardiovascular system; Carrying Capacities; Cessation of life; Classification; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Data Monitoring Committees; Communities; Congestive Heart Failure; Coronary heart disease; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Reporting; Data Set; Databases; Drops; Electrocardiogram; Ensure; Event; Exclusion Criteria; Guidelines; Hemoglobin; Hemoglobin concentration result; Hospitals; Human Resources; Immunity; Incidence; Infrastructure; Intention; Intervention; Leadership; Length of Stay; Manuals; Manuscripts; Measures; Mediator of activation protein; Medical; Methods; Monitor; Myocardial Infarction; Myocardial Ischemia; National Heart, Lung, and Blood Institute; Outcome; Oxygen; Patient-Focused Outcomes; Patients; Pilot Projects; Pneumonia; Positioning Attribute; Preparation; Procedures; Process; Protocols documentation; Quality Control; Quality Indicator; Quality of Care; Randomized; Randomized Clinical Trials; Recurrence; Reporting; Risk; Scheme; Shapes; Site; Specific qualifier value; Statistical Data Interpretation; System; Thromboembolism; Training; Transfusion; Treatment Effectiveness; Uncertainty; United States; United States National Institutes of Health; Universities; Variant; Wood material; Writing; adverse outcome; base; clinical center; clinical practice; clinical research site; data centers; data management; data quality; data resource; design; epidemiologic data; experience; high risk; hospital readmission; inclusion criteria; medical schools; mortality; mortality risk; operation; patient population; pilot trial; pragmatic trial; systematic review; thrombotic; treatment strategy; user-friendly

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.

项目摘要 来自临床试验的积累证据表明，在大多数临床上，限制性输血策略是安全的 设置。然而，对中度贫血的低氧气承载能力可能是有害的 心脏缺血。急性症状冠状动脉患者的贫血与贫血相关的伤害的潜力 疾病得到了病理生理数据的支持，该数据维持较高的血红蛋白水平可以使 缺血性心脏通过增加氧气递送。此外，发现110例患者薄荷试验试验的结果 通过自由输血策略，1名患者（1.8％），30天的全因死亡率较少， 与限制性输血策略相比，有7名患者（13.0％）（p = 0.032）。临床的系统评价 评估已知缺血性心脏病患者输血策略的试验证明没有 高质量的数据导致了持续的争议。缺乏指导的高质量证据 急性心肌梗塞患者的输血已在几个主要指南中引用 由NIH专家小组。尽管如此，输血仍被用作质量的负面指标 大型组织的照顾，推动采用限制性策略。不良结果的潜力是 真实而直接的。 在这项多中心务实的试验中，我们将激活40个临床中心，并将随机分配3500名患者 急性心肌梗塞和血红蛋白浓度小于10 g/dL的风险 根据限制性或自由输血策略进行治疗。我们的主要目的是 确定自由输血阈值策略（10 g/dl）是否优越，并将导致较低的比率 所有这些都在随机分组后30天内引起死亡率或急性心肌梗塞 具有限制性输血阈值策略（8 g/dl）。我们的次要目标将研究自由主义的效果 输血策略与对输血不良后果的限制输血策略相比 与体积过载，血小板风险和修饰的免疫力有关。我们将比较30天 充血性心力衰竭，血栓栓塞和肺炎。我们还将比较30天死亡率， 心血管死亡，心肌梗死和外部血运重建以及医院长度的 留下来，再入院。我们将在6个月时与患者联系，以确定早期影响是否 死亡率是持续的或可能增强的。 关联 薄荷的定位是确定急性心肌梗塞患者输血的阈值 最大程度地减少死亡并随后的心脏病发作。考虑到急性心肌梗塞的高发病率 薄荷的结果可以塑造临床实践。