Catheter-Directed Thrombolytic Therapy: Deep 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.