2008© COPYRIGHT Thrombosis and Hemostasis Centers Research and Prevention Network Centers for Disease Control & Prevention Thomas L. Ortel, M.D., Ph.D. Director, Duke Hemostasis & Thrombosis Center Director, Duke Anticoagulation Management Service Professor of Medicine & Pathology, Duke University Medical Center

Integrating Prevention Services for Persons with Bleeding and Clotting Disorders “Assess efficacy of integrated, multi-disciplinary care & prevention services for patients with bleeding and clotting disorders.” “Assess unmet needs and identify outreach strategies.” “Develop effective messages aimed at disease management & prevention.” “Develop training programs.” Federal Register announcement, June 2001

Hemostasis and Thrombosis Centers: Pilot Sites -Mayo Clinic Rochester, MN Robert Wood Johnson Medical Center, New Brunswick, NJ -Michigan State University, Lansing, MI -Wayne State University, Detroit, MI -University of Michigan, Ann Arbor, MI Mountain States Regional HTC, Denver, CO -Duke University, Durham, NC -UNC Chapel Hill, NC

Thrombosis and Hemostasis Centers Pilot Sites Program Initial Objectives & Goals Develop and implement a database to track patients seen at the Centers (initial focus on outpatients in thrombosis clinics). Initial publication describing the Program. Develop protocols for review and implementation of research studies to be conducted through the program.

Patient Registry The patient registry began enrollment in August As of 31 July 2007, 4,250 patients have been enrolled for 8,411 visits. Number of visits ranges from 2 to 99 (mean=2). 347 patients were referred for bleeding reasons only, leaving 3,803 participants referred for evaluation of thrombosis or thrombosis risk.

Initial Publication

Registry-based Investigations Thornburg C, Beckman M, Thames E, Brancazio L, Ortel T, James A. Thrombosis and Hemostasis Centers pilot sites registry: maternal thrombophilia. J.Thromb.Haemost., 2007; 5 Supplement 2: P-W-597. Thornburg C, Beckman M, Dowling N, Michaels L, Manco-Johnson M, Pipe S, Kulkarni R. Thrombosis and Hemostasis Centers Pilot Sites Registry: Thrombophilia Screening in Children. J.Thromb.Haemost., 2007; 5 Supplement 2: P-W-468.

Limitations to Registry-Driven Research Certain data collected but not used for specific research studies. Certain data fields of limited value (e.g., laboratory results normal vs. abnormal). Family history data largely self-reported. Follow-up driven by return clinic visits rather than for outcomes studies. Follow-up variable by site.

Continuation of the Thrombosis and Hemostasis Centers Research and Prevention Network (U01) Collaboratively develop research, educational objectives, and establish diagnostic and therapeutic standards for patients with complex thrombotic and hemorrhagic disorders. Enhance patient care… Develop and implement a research agenda… Promote training opportunities in thrombosis and hemostasis… RFA-DD ; Jan 2007

Thrombophilia Network Research Proposals Case-control, genome-wide association study in African Americans (PI, John Heit, MD). Identification of patients at high-risk for recurrent venous thromboembolism by gene expression analysis (PI, Thomas Ortel, MD, PhD). Determine long-term outcomes in children with venous thromboembolism (PI, Marilyn Manco- Johnson, MD).

Future Directions Enhance applicability of the registry for hypothesis-driven research projects by developing specific modules. Development of repository for serum, plasma, genomic DNA samples for future testing. Development of prospective clinical research studies. Expand the number of participating sites…

Questions and Issues to Consider Can data collection for CDC Thrombosis site registry and ATHN occur at the same site? –More than one consent form required for different purposes? Or one consent form with check boxes? –Common data elements collected and entered once, stored in both resources. –Unique data separately allocated and stored at the data entry level. –How to accommodate additional registries (HTRS)?