2/2 Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT Trial) –DCC

2/2 肺栓塞：导管定向治疗血栓清除（PE-TRACT 试验）—DCC

基本信息

批准号：
10448731
负责人：
THADDEUS TARPEY
金额：
$ 62.28万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-01 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10448731
关键词：
Activities of Daily Living Acute Anticoagulant therapy Anticoagulation Benefits and Risks Berry Biometry Blinded Blood Pressure Budgets Cardiopulmonary Catheters Cessation of life Clinical Clinical Trials Clinical Trials Data Monitoring Committees Clinical Trials Design Coagulation Process Consultations Cost Effectiveness Analysis Dangerousness Data Data Analyses Data Collection Data Coordinating Center Data Set Databases Deterioration Disease Dose Economics Enrollment Ensure Event Excision Exercise Test Fibrinolytic Agents Futility Gatekeeping Goals Health Heart Hemorrhage Infrastructure Measures Methodology Mission National Heart, Lung, and Blood Institute New York Outcome Outcome Study Oxygen Consumption Patients Phase Pragmatic clinical trial Procedures Process Protocol Compliance Public Health Publications Pulmonary Embolism Pulmonary artery structure Quality Control Quality of life Quality-Adjusted Life Years Randomized Randomized Controlled Trials Recurrence Reporting Research Design Resources Right Ventricular Dysfunction Right Ventricular Function Risk Sample Size Security Standardization Statistical Data Interpretation Testing Therapy trial Thrombolytic Therapy Thrombus Time Walking Work Writing adjudication adverse event monitoring clinical center clinical practice cost data de-identification data integrity data quality data repository data resource design disability effectiveness study efficacy outcomes exercise capacity experience feasibility trial follow-up functional status improved incremental cost-effectiveness innovation open label prevent primary outcome randomized trial safety outcomes screening thrombolysis treatment group trial design venous thromboembolism

项目摘要

PROJECT SUMMARY The optimal management of patients with submassive pulmonary embolism (PE), who have right heart dysfunction but a normal blood pressure, is uncertain. These patients are at risk for poor short-term outcomes, suffer from reduced functional capacity, and have lower quality of life over the long term. While systemic thrombolysis reduces clinical deterioration from PE, this benefit is offset by substantial increases in major and intracranial bleeding. Catheter-directed therapy (CDT), which dissolves pulmonary artery thrombus with a much lower dose of thrombolytic drug, may be as effective as systemic thrombolytic therapy without substantially increasing bleeding, but it has risks and is costly, and it is not known if it improves cardiopulmonary heath, particularly over the long term. We therefore plan to conduct an open-label, assessor-blinded, randomized trial, the Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT) Study, to compare CDT with No-CDT in up to 500 patients with submassive PE. The trial is adaptive, and could result in enrollment being stopped early for superior efficacy or for futility at an interim analysis. There will be two primary efficacy outcomes: peak oxygen consumption at 3 months (short-term) and New York Heart Association (NYHA) class at 12 months (long-term), analyzed sequentially using a gatekeeping approach; for NYHA class to be compared, peak oxygen consumption must first be shown to be increased by CDT (P<0.05). The primary safety outcome will be major bleeding within 30 days of randomization. The Data Coordinating Center, led by experts with deep experience in adaptive and pragmatic clinical trial design and implementation, will oversee all aspects of study design, implementation, and analysis, and will provide state-of-the-art data collection and quality control infrastructure, reporting to the independent Data and Safety Monitoring Board, and provision of data and resources to the public. The PE-TRACT Study will change clinical practice: if CDT is effective and safe, it will become part of standard therapy for patients with submassive PE; if not, a risky and costly therapy will be avoided. Hence, either study outcome will improve public health and advance the NHLBI’s mission

项目概要右心衰竭的次大面积肺栓塞 (PE) 患者的最佳治疗功能障碍但血压正常，这些患者面临短期结果不佳的风险，患有功能能力下降，并且长期生活质量较低。溶栓治疗可减少 PE 引起的临床恶化，但这一益处被主要和主要疾病的大幅增加所抵消。颅内出血。导管定向治疗（CDT），通过导管溶解肺动脉血栓。溶栓药物剂量低得多，可能与全身溶栓治疗一样有效，无需出血量大幅增加，但有风险、成本高，能否改善尚不得而知心肺健康，尤其是长期的。因此，我们计划进行一项开放标签、评估者盲法、随机试验，即肺栓塞：导管定向治疗血栓清除 (PE-TRACT) 研究，比较 CDT 与 No-CDT 该试验有多达 500 名次大面积肺栓塞患者参与，可能会导致招募被停止。尽早获得卓越疗效或在中期分析中无效将有两个主要疗效结果：峰值。 3 个月（短期）时的耗氧量和 12 个月时纽约心脏协会 (NYHA) 级别的耗氧量（长期），使用守门方法按顺序分析要比较的 NYHA 类别、峰值；首先必须证明 CDT 会增加耗氧量（P<0.05）。随机分组后 30 天内发生大出血。数据协调中心由资深专家领导。在适应性和务实的临床试验设计和实施方面的经验，将监督研究的各个方面设计、实施和分析，并将提供最先进的数据收集和质量控制基础设施，向独立的数据和安全监测委员会报告，并提供数据和 PE-TRACT 研究将改变临床实践：如果 CDT 有效且安全，它将改变临床实践。成为次大面积肺栓塞患者标准治疗的一部分；如果不这样做，治疗将是一种危险且昂贵的治疗方法。因此，无论哪种研究结果都将改善公众健康并推进 NHLBI 的使命