CHRONIC VENOUS THROMBOSIS: RELIEF WITH ADJUNCTIVE CATHETER-BASED THERAPY (C-TRACT

慢性静脉血栓形成：基于辅助导管的治疗（C-TRACT）缓解

• 批准号: 8757713
• 负责人: SURESH VEDANTHAM
• 金额: $ 34.28万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8757713
• 关键词: Accountability; Acute; Address; Adverse event; Affect; Anatomy; Applications Grants; Automobile Driving; Award; Case Report Form; Catheters; Chronic; Clinical; Clinical Research; Clinical Research Protocols; Clinical Sciences; Clinical Trials; Clinical Trials Design; Clinical trial protocol document; Communities; Complication; Consensus; Credentialing; Data; Data Coordinating Center; Databases; Deep Vein Thrombosis; Dermatitis; Development; Devices; Disease; Edema; Effectiveness; Enrollment; Environment; Exhibits; Goals; Grant; Health; Iliac Vein; Image; Impairment; Institutes; Institutional Review Boards; Interdisciplinary Study; Internet; Intervention; Label; Leg Ulcer; Limb structure; Lower Extremity; Manuals; Medical; Minority; Modality; Monitor; National Heart, Lung, and Blood Institute; Obstruction; Outcome Assessment; Outcome Measure; Pain; Patient Recruitments; Patients; Physiological; Postphlebitic Syndrome; Preparation; Procedures; Process; Professional Organizations; Protocol Compliance; Protocols documentation; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reflux; Request for Proposals; Research Infrastructure; Research Personnel; Resource Development; Risk; Safety; Sample Size; Severities; Site; Specific qualifier value; Stents; Subgroup; Symptoms; Thermal Ablation Therapy; TimeLine; Translational Research; Universities; Update; Venous; Venous Thrombosis; Washington; Work; abstracting; adverse outcome; arm; base; claudication; clinical phenotype; clinical practice; cost; daily functioning; disability; economic outcome; effective therapy; evidence base; experience; health related quality of life; improved; innovation; mobile application; multidisciplinary; neglect; novel; patient advocacy group; patient population; programs; public health relevance; screening; social; tool; treatment strategy; web site

DESCRIPTION (provided by applicant): Patients with severe iliac-obstructive post-thrombotic syndrome (SIO-PTS), a rare complication of lower extremity deep vein thrombosis (DVT), experience profound disability and quality of life (QOL) impairment. Because there is a lack of evidence-based therapy for SIO- PTS, affected patients tend to have their condition either neglected or managed by poorly- justified local opinion. Our long-term goals are two-fold: 1) to validate effective therapy that can reduce PTS symptoms and restore our unfortunate patients with SIO-PTS to better health, limb function, and QOL; and 2) to extend the range of expertise within the clinical trial infrastructure we developed for an ongoing NHLBI-sponsored trial of catheter-based therapy for acute DVT (the ATTRACT Trial) to be able to address challenges in the treatment of chronic DVT and PTS. Our main objective of the current application for a U34 Clinical Trial Planning Grant is to refine and finalize the development of the clinical research protocol and trial capability that are needed to launch the Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Based Therapy (C-TRACT) Study, a multicenter randomized controlled trial that will rigorously determine if the benefits of an innovative strategy of imaging-guided endovascular treatment for patients with established SIO-PTS outweigh the risks and costs. By combining diligent planning, expertise with advanced methodological and biostatistical trial designs (provided by the U24 Clinical Trials Development Resource for Hematologic Disorders), and systematic efforts to engage community partners, we expect to create A) an outstanding clinical trial protocol; B) the potential to rapidly enroll and complete the proposed study; and C) multidisciplinary research groups that can ultimately serve as regional leaders in driving best clinical practices and future research studies to address the needs of patients with chronic DVT and PTS.

描述（由申请人提供）：患有重度髂动脉阻塞性血栓后综合征（SIO-PTS）的患者，下肢深静脉血栓形成（DVT）的一种罕见并发症，经历严重残疾和生活质量（QOL）受损。由于缺乏针对SIO-PTS的循证治疗，受影响的患者往往被忽视或被不合理的当地意见管理。我们的长期目标是双重的：1）验证有效的治疗方法，可以减少PTS症状，并恢复我们不幸的SIO-PTS患者更好的健康，肢体功能和生活质量;以及2）扩展我们为NHLBI赞助的正在进行的急性DVT导管治疗试验开发的临床试验基础设施内的专业知识范围（ATTRACT试验）能够应对慢性DVT和PTS治疗中的挑战。我们目前申请U34临床试验计划资助的主要目的是完善和完成启动慢性静脉血栓形成所需的临床研究方案和试验能力的开发：辅助导管治疗缓解（C-TRACT）研究，一项多中心随机对照试验，将严格确定一种创新的成像策略的益处-对已确诊SIO-PTS患者的引导血管内治疗超过了风险和成本。通过结合勤奋的规划、先进的方法学和生物统计学试验设计（由U24血液病临床试验开发资源提供）的专业知识以及与社区合作伙伴的系统性努力，我们期望创建A）出色的临床试验方案; B）快速招募和完成拟议研究的潜力;以及C） 多学科研究小组，最终可以作为区域领导者，推动最佳临床实践和未来的研究，以满足慢性DVT和PTS患者的需求。