Data Coordinating Centre for ATTRACT Trial

ATTRACT 试验数据协调中心

基本信息

批准号：
7665029
负责人：
Clive Kearon
金额：
$ 47.69万
依托单位：
MCMASTER UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-07-29 至 2013-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7665029
关键词：
Acute Aftercare Anatomy Anticoagulant therapy Arts Blinded Catheters Cessation of life Clinical Clinical Trials Data Monitoring Committees Clinical Trials Design Communities Data Data Collection Data Coordinating Center Data Set Databases Deep Vein Thrombosis Diagnosis Disease Economics Elements Enrollment Event Excision Frequencies Generic Drugs Goals Health Care Costs Hematological Disease Hemorrhage Iliac Vein Image Impairment Leg Ulcer Life Style Low Prevalence Measurement Medical Methods Minor Mission Morbidity - disease rate Negative Finding Outcome Outcome Measure Outcome Study Parents Patients Phase Phlebography Postphlebitic Syndrome Prevention Prevention strategy Procedures Process Protocols documentation Public Health Publications Quality of life Randomized Randomized Controlled Clinical Trials Randomized Controlled Trials Recurrence Reflux Reliance Reporting Research Residual state Resolution Safety Sample Size Screening procedure Secure Severities Symptoms Thrombus Translating Treatment outcome Veins Venous Venous Thrombosis Work Writing adjudication clinical practice clinically significant cost effectiveness design disability follow-up improved innovation open label prevent risk benefit ratio thrombolysis

项目摘要

Description (provided by applicant): Post-Thrombotic Syndrome (PTS) develops frequently (25-50%) in patients with proximal deep vein thrombosis (DVT) despite the use of standard anticoagulant therapy. PTS leads to lifestyle-limiting symptoms, work disability, leg ulcers, quality of life (QOL) impairment, and major healthcare costs. Preliminary studies indicate that image-guided Endovascular Thrombus Removal procedures can rapidly restore deep venous patency and thereby prevent PTS in acute proximal DVT patients. However, these studies are limited by reliance upon surrogate anatomic outcome measures of limited clinical significance, non-randomized design, single-center design, and small sample size. For this reason, there currently exists major controversy within the medical community as to whether or not Endovascular Thrombus Removal should be routinely used in the first-line treatment of acute proximal DVT. The long-term goal of the proposed project is to determine whether Endovascular Thrombus Removal should be translated into widespread, first-line use in patients with acute DVT. In the proposed study, we will conduct a Phase III, multicenter, open label, assessor-blinded, randomized controlled trial entitled "Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)" to determine whether the use of Pharmacomechanical Catheter-Directed Thrombolysis (PCDT), a state-of-the-art Endovascular Thrombus Removal method, results in a) a lower prevalence of PTS and b) superior quality of life (QOL), two clinically important treatment outcomes, in symptomatic, first episode, acute proximal DVT patients. The proposed research is both innovative and significant. The study will be the first multicenter randomized trial to evaluate a state-of-the-art image-guided endovascular strategy for the prevention of PTS. If the study establishes a favorable risk-benefit ratio for PCDT, this finding will fundamentally change clinical practice and enable prevention of PTS in thousands of DVT patients. If PCDT does not prevent PTS or if its risk-benefit ratio proves to be unfavorable, this finding will reduce or eliminate the routine use of a costly and potentially risky therapy. Hence, either outcome of the proposed study will greatly improve clinical practice and decrease morbidity in patients with acute DVT, a common blood disorder. Therefore, the study will clearly improve public health and advance the NHLBI's mission. Project Narrative: The ATTRACT Trial will determine whether Pharmacomechanical Catheter-Directed Thrombolysis can prevent the Post-Thrombotic Syndrome (PTS) in patients with Deep Vein Thrombosis (DVT). If the Trial is positive, this finding will conclusively validate the "Open Vein Hypothesis" and thereby a) immediately enable prevention of PTS, a common, morbid, and expensive condition, in thousands of DVT patients each year; and b) catalyze a fundamental shift towards a new treatment paradigm in which early venous thrombus removal is considered an essential element of initial DVT therapy. If the Trial is negative, this finding will eliminate the routine use of a costly and potentially dangerous therapy. Hence, either study outcome will decrease morbidity from DVT, improve public health, and advance the NHLBI's mission.

描述（由申请人提供）：尽管使用了标准抗凝治疗疗法，但近端深静脉血栓形成（DVT）患者的血栓形成综合征（PT）经常出现（25-50％）。 PTS导致限制生活方式的症状，工作障碍，腿部溃疡，生活质量（QOL）障碍和重大医疗保健费用。初步研究表明，图像引导的内血管血栓切除程序可以快速恢复深静脉通畅，从而防止急性近端DVT患者的PT。但是，这些研究受到依赖替代解剖结局指标的限制，其临床意义有限，非随机设计，单中心设计和较小的样本量。因此，医学界目前存在有关是否应定期用于急性近端DVT的一线治疗中的血管血管血管血管中的重大争议。拟议项目的长期目标是确定是否应将急性DVT患者中的一线用途转化为一线使用。 In the proposed study, we will conduct a Phase III, multicenter, open label, assessor-blinded, randomized controlled trial entitled "Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT)" to determine whether the use of Pharmacomechanical Catheter-Directed Thrombolysis (PCDT), a state-of-the-art Endovascular Thrombus Removal method, results in a) a lower PTS和B）较高的生活质量（QOL）的患病率，两种临床上重要的治疗结果，有症状，第一事件，急性近端DVT患者。拟议的研究既具有创新又具有重要意义。该研究将是第一个评估预防PT的最先进图像引导的内血管内策略的多中心随机试验。如果该研究对PCDT建立了有利的风险效益比，那么这一发现将从根本上改变临床实践，并能够预防数千名DVT患者的PT。如果PCDT不能阻止PT或证明其风险效益比不利，则此发现将减少或消除常规使用昂贵且潜在的风险疗法。因此，拟议的研究的结果将大大改善急性DVT患者（一种常见的血液疾病）患者的临床实践并降低发病率。因此，这项研究将明显改善公共卫生并提高NHLBI的使命。项目叙述：吸引试验将确定药物力学导管指导的溶栓是否可以防止深静脉血栓形成（DVT）患者的血栓形成综合征（PTS）。如果试验是积极的，则该发现将最终验证“开放静脉假设”，从而a）每年在数千名DVT患者中立即预防PT，一种常见，病态且昂贵的状况； b）催化向新的治疗范式的基本转变，其中早期的静脉血栓切除被认为是初始DVT治疗的重要因素。如果试验为阴性，这一发现将消除常规使用昂贵且潜在的危险疗法。因此，研究结果将降低DVT的发病率，改善公共卫生并提高NHLBI的使命。