Catheter-Directed Thrombolytic Therapy: Deep Thrombosis

描述(由申请人提供)： 候选人？S的长期目标是在以下领域发展事业 某学术卫生中心的临床止血和血栓形成研究 环境。在这项提案中，他将研究预防 血栓后综合征(PTS)，深静脉血栓形成(DVT)的常见后遗症。 拟议的职业发展计划包含了一个多方面的课程。 这包括结构化的教学课程，旨在增强他以前的 临床研究硕士课程，参与临床和 研究研讨会，以及紧张的、密切指导的临床研究 经验。在他的赞助商、共同赞助商和顾问的指导下， 考生将进行一项由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临床对比研究 治疗近端深静脉血栓的主要目标是减少 PTS。初步研究将辅之以对数据的回顾分析。 收集自十年导管定向溶栓治疗经验 在明尼苏达大学，专门评估血栓溶解率，以及 不良事件。他还将审查所有患者的医疗记录 在1997-2000年期间被诊断为深静脉血栓，以估计 可能有资格参加临床试验的患者使用 试点研究的拟议资格标准。最后，候选人将 综合从回顾分析和试点中吸取的经验教训 研究，在他的咨询委员会的指导下，他将建立 进行最终临床试验所需的研究基础设施。这个 建议的课程将帮助应聘者获得技术和学术知识 成为一名独立的临床研究员所需的技能。这会有帮助的 他促进了参与的各个教职员工之间的密切联系 开展试点研究，并协助形成调查员网络 有着共同的兴趣，从而促进了未来研究的合作。

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.