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

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 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 设置.然而，中度贫血导致的携氧能力低下可能对患有贫血的患者有害。 心肌缺血急性症状性冠状动脉粥样硬化性心脏病患者贫血相关伤害的可能性 病理生理学数据支持了这种疾病，即保持较高的血红蛋白水平可以使 缺血性心脏通过增加氧气输送。此外，110名患者的MINT试点试验结果发现， 采用自由输血策略时30天时的全因死亡率较低，1例患者（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， 高质量的数据导致了持续的争议。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中引用， 一个NIH专家小组。尽管如此，输血仍被用作一个负面指标， 主要组织的关心推动了限制性策略的采用。不良后果的可能性是 真实的和即时的。 在这项多中心的务实试验中，我们将启动40个临床中心，并将随机分配3500名患者， 急性心肌梗死和血红蛋白浓度低于10 g/dL的心肌缺血风险， 根据限制性或自由输血策略进行治疗。我们的主要目标是 确定自由输血阈值策略（10 g/dL）是否具有上级优势，并将导致较低的 随机化后30天内的全因死亡或急性心肌梗死， 限制性输血阈值策略（8 g/dL）。我们的第二个目标将检查一个自由主义者的影响。 输血策略与限制性输血策略对输血不良结局的比较 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和肺炎我们还将比较30天内的死亡率， 心血管死亡、心肌梗死和计划外血运重建，以及 留下，再入院。我们将在6个月时联系患者，以确定早期影响是否 对死亡率的影响是持续的或可能增强的。 相关性 MINT定位于确定急性心肌梗死患者的输血阈值 以尽量减少死亡和随后的心脏病发作。鉴于急性心肌梗死的高发病率， MINT的结果可以塑造临床实践。