Catheter-Directed Thrombolytic Therapy: Deep Thrombosis

导管定向溶栓治疗：深部血栓形成

• 批准号: 7001343
• 负责人: ANEEL ARJUN ASHRANI
• 金额: --
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-01-07 至 2006-03-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7001343
• 关键词: anticoagulants; catheterization; chemoprevention; clinical trials; drug delivery systems; experimental designs; fibrinolysis; human data; human subject; human therapy evaluation; medical complication; patient oriented research; venous thrombosis

DESCRIPTION (provided by applicant): The candidate?s long-term objective is to develop a career in the field of clinical hemostasis and thrombosis research in an academic health center environment. In this proposal, he will investigate strategies to prevent postthrombotic syndrome (PTS), a common sequel of deep vein thrombosis (DVT). The proposed career development plan incorporates a multi-faceted curriculum. This includes structured didactic courses designed to augment his previous Masters in Clinical Research curriculum, participation in clinical and research seminars, and an intense, closely mentored, clinical research experience. With the guidance of his sponsor, co-sponsor, and consultants, the candidate will conduct a pilot study comprised of 30 subjects to evaluate the feasibility of a subsequent multi-center, open label, randomized clinical trial comparing thrombolytic therapy to standard anticoagulation in the treatment of proximal DVT, with the primary goal of reducing the incidence of PTS. The pilot study will be complemented by a retrospective analysis of data gathered from a ten-year experience of catheter-directed thrombolytic therapy at the University of Minnesota, specifically evaluating clot lysis rate, and adverse events. He will also review the medical records of all the patients diagnosed with DVT during the period 1997-2000, to estimate the proportion of patients who would potentially be eligible for the clinical trial using the proposed eligibility criteria of the pilot study. Finally, the candidate will synthesize lessons learned from the retrospective analyses and the pilot study, and under the guidance of his Advisory Committee, he will establish the required research infrastructure to conduct the definitive clinical trial. The proposed curriculum will help the candidate acquire technical and academic skills required to become an independent clinical investigator. It will help him foster a close link between the various faculty members participating in the pilot study, and facilitate the formation of a network of investigators with common interests, thus promoting collaborations for future studies.

描述（由申请人提供）： 候选人？的长期目标是发展在该领域的职业生涯 一个学术卫生中心的临床止血和血栓形成研究 环境在这份提案中，他将研究防止 血栓后综合征（PTS）是深静脉血栓形成（DVT）的常见后遗症。 拟议的职业发展计划包括多方面的课程。 这包括结构化的教学课程，旨在加强他以前的 临床研究硕士课程，参与临床和 研究研讨会，以及密集的，密切指导的临床研究 体验.在他的赞助商、共同赞助商和顾问的指导下， 候选人将进行一项由30名受试者组成的试点研究，以评估 后续多中心、开放标签、随机临床试验的可行性 溶栓治疗与标准抗凝治疗的比较试验 治疗近端DVT，主要目标是降低 重量份试点研究将辅之以回顾性数据分析 根据10年的导管溶栓治疗经验， 在明尼苏达大学，专门评估凝块溶解率， 不良事件。他还将审查所有病人的医疗记录 在1997 - 2000年期间诊断为DVT的患者中， 可能有资格参加临床试验的患者 试点研究的拟议资格标准。最后，候选人将 综合从回顾性分析和试点中吸取的经验教训 他将在其咨询委员会的指导下， 需要研究基础设施来进行最终的临床试验。的 拟议的课程将帮助候选人获得技术和学术 成为独立临床研究者所需的技能。它将帮助 他促进了参与各种教师之间的密切联系， 试点研究，并促进建立一个调查员网络 有共同的兴趣，从而促进合作，为未来的研究。