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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23HL069203-02
Application #
6620746
Study Section
Special Emphasis Panel (ZHL1-CSR-F (O1))
Program Officer
Mondoro, Traci
Project Start
2002-01-07
Project End
2006-12-31
Budget Start
2003-01-01
Budget End
2003-12-31
Support Year
2
Fiscal Year
2003
Total Cost
$132,510
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Ashrani, Aneel A; Silverstein, Marc D; Rooke, Thom W et al. (2010) Impact of venous thromboembolism, venous stasis syndrome, venous outflow obstruction and venous valvular incompetence on quality of life and activities of daily living: a nested case-control study. Vasc Med 15:387-97
Ashrani, Aneel A; Silverstein, Marc D; Lahr, Brian D et al. (2009) Risk factors and underlying mechanisms for venous stasis syndrome: a population-based case-control study. Vasc Med 14:339-49
Ashrani, Aneel A; Heit, John A (2009) Incidence and cost burden of post-thrombotic syndrome. J Thromb Thrombolysis 28:465-76
Ashrani, A A; Key, N S; Soucie, J Michael et al. (2008) Septic arthritis in males with haemophilia. Haemophilia 14:494-503
Ashrani, A A; Gabriel, D A; Gajewski, J L et al. (2006) Pilot study to test the efficacy and safety of activated recombinant factor VII (NovoSeven) in the treatment of refractory hemorrhagic cystitis following high-dose chemotherapy. Bone Marrow Transplant 38:825-8