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1/2 Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT Trial)

1/2 肺栓塞：导管定向治疗血栓清除（PE-TRACT 试验）

基本信息

批准号：
10449712
负责人：
Sunil Rao
金额：
$ 219.03万
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 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10449712
关键词：
Activities of Daily Living Acute American Anticoagulant therapy Anticoagulation Award Benefits and Risks Berry Blinded Blood Pressure Cardiopulmonary Cardiopulmonary Physiology Catheters Cessation of life Chronic Clinical Clinical Trials Clinical Trials Network Coagulation Process Consultations Dangerousness Deterioration Disease Dose Enrollment Excision Exercise Test Fibrinolytic Agents Futility Gatekeeping Grant Health Heart Hemorrhage Impairment Measures Methodology Mission National Heart, Lung, and Blood Institute New York Outcome Outcome Study Oxygen Consumption Patients Peripheral Phase Prediction of Response to Therapy Procedures Professional Organizations Public Health Pulmonary Embolism Pulmonary artery structure Quality of life Quality-Adjusted Life Years Randomized Randomized Controlled Trials Recurrence Research Priority Resources Right Ventricular Dysfunction Right Ventricular Function Risk SF-36 Sample Size Science Shortness of Breath Survivors Symptoms Techniques Technology Testing Therapy trial Thrombolytic Therapy Thrombus Veins Walking base clinical practice cost cost effectiveness disability efficacy outcomes efficacy study exercise capacity feasibility trial functional status hemodynamics high risk image guided improved incremental cost-effectiveness innovation mortality open label optimal treatments prevent randomized trial safety outcomes secondary outcome symposium targeted delivery thrombolysis treatment group 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. In addition to being at risk for poor short-term outcomes, these patients suffer from reduced functional capacity and a 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, appears to be as effective as systemic thrombolytic therapy without substantially increasing bleeding. Consequently, CDT is often used in the U.S. to treat submassive PE. However, CDT has risk and is costly, and it is not known if it improves cardiopulmonary heath, particularly over the long-term. We therefore plan to do 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 500 patients with submassive PE. We will use an "adaptive sample size" which could result in enrollment being stopped 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 NYHA class at 12 months (long-term). These will be 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. Secondary outcomes include generic quality of life (QOL) (SF- 36), 6-minute walk distance, clinical deterioration from PE, and cost-effectiveness. Exploratory analyses will assess: disease-specific QOL, other cardiopulmonary exercise test parameters, recurrent venous thromboembolism and complications of the CDT procedure. Predictors of therapeutic response will also be sought. 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，是不确定的。 In addition to being at risk for poor short-term 结果是，从长远来看，这些患者的功能能力下降，生活质量较低。虽然全身溶栓可减少 PE 引起的临床恶化，但这种益处会被大量的药物所抵消。 increases in major and intracranial bleeding.导管定向治疗 (CDT)，可溶解肺部用低得多剂量的溶栓药物治疗动脉血栓，似乎与全身治疗一样有效溶栓治疗不会显着增加出血。 Consequently, CDT is often used in the U.S. to 治疗次大面积PE。但CDT有风险，费用高，是否改善心肺功能尚不清楚 heath, particularly over the long-term. 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 500 patients with submassive PE.我们将使用“自适应样本量”，这可能会导致注册因疗效优异或因中期分析无效而停止。 There will be two primary efficacy 结果； 3 个月时达到峰值耗氧量（短期），12 个月时达到 NYHA 等级（长期）。这些将使用“把关”方法按顺序进行分析； for NYHA class to be compared, peak 首先必须证明 CDT 会增加耗氧量 (P<0.05)。 The primary safety outcome will be major bleeding within 30 days of randomization.次要结果包括一般生活质量 (QOL) (SF- 36）、6 分钟步行距离、PE 导致的临床恶化以及成本效益。 Exploratory analyses will 评估：特定疾病的生活质量、其他心肺运动测试参数、静脉回流 CDT 手术的血栓栓塞和并发症。 Predictors of therapeutic response will also be 寻求。 PE-TRACT 研究将改变临床实践：如果 CDT 有效且安全，它将成为次大面积肺栓塞患者的标准治疗；如果不这样做，就可以避免危险且昂贵的治疗。因此，任何一项研究结果都将改善公众健康并推进 NHLBI 的使命。