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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.

项目摘要右心次大面积肺栓塞（PE）患者的最佳治疗功能障碍但血压正常，是不确定的。除了面临短期不良风险外，结果，这些患者长期遭受功能能力降低和生活质量降低。虽然全身溶栓减少了PE的临床恶化，但这种益处被大量的严重和颅内出血增加。导管导向治疗（CDT），动脉血栓与低剂量的溶栓药物，似乎是有效的全身溶栓治疗不会大幅增加出血。因此，CDT在美国经常用于治疗次大块肺栓塞但CDT有风险且成本高，是否改善心肺功能尚不得而知健康，尤其是长期。因此，我们计划进行一项开放标签、评估者设盲、随机试验，即肺栓塞：导管引导治疗血栓清除（PE-TRACT）研究，比较CDT与无CDT患者的 500例次大块PE患者。我们将使用“自适应样本量”，这可能会导致入组在中期分析时因上级疗效或无效而停止。将有两个主要功效结果; 3个月时的峰值耗氧量（短期）和12个月时的NYHA分级（长期）。将使用“把关”方法对这些进行顺序分析;对于要比较的NYHA分级，峰值氧耗量必须首先显示出CDT增加（P<0.05）。主要安全性结局将是随机化前30天内发生大出血。次要结局包括一般生活质量（QOL）（SF-1）。 36）、6分钟步行距离、PE临床恶化和成本效益。探索性分析评估：疾病特异性QOL、其他心肺运动试验参数、复发性静脉血栓栓塞和CDT手术并发症。治疗反应的预测因素也将是寻找。PE-TRACT研究将改变临床实践：如果CDT有效且安全，它将成为次大规模PE患者的标准治疗;如果没有，将避免风险和昂贵的治疗。因此，我们认为，任何一项研究结果都将改善公众健康，推进NHLBI的使命。