HTRS Registry

The Hemophilia & Thrombosis Research Society has established a national patient registry through which a common set of data are collected from Hemophilia Treatment Centers in an effort to gain a better understanding of the pathophysiology, current clinical management and outcomes of patients with coagulation disorders. Known as the HTRS Registry, the initial objectives are:

• 1. To provide insight into variation in the management of hemophilia and the association between particular patterns of practice and patient outcomes;
• 2. To gain further insight into the natural history of patients with coagulation factor inhibitors, and the safety and effectiveness of alternative treatments for such inhibitors;
• 3. To systematically assess the use, effectiveness and safety of alternative therapy for acute bleeding episodes in patients with hemophilia.

Support

The HTRS Registry is initially being supported by a generous grant from NovoNordisk and will also assist NovoNordisk with their FDA–mandated effort to systematically assess the safety and efficacy of NovoSeven in large numbers of patients. However, the HTRS and not NovoNordisk, retains ownership of the data and the right to determine how the data are published and utilized; each investigator has access to and control of his/her own data as well. It is anticipated that the data collection in this Registry will support multiple HTRS studies in the future and be supported by several mechanisms.

The Database

The database itself is being created and maintained at Covance, a well–respected company known for it's work in clinical research. The data entry software is protected and fully encrypted to prevent unauthorized viewing of the data. Each investigator will have on–line access to data specific to their HTC as well as aggregate data from all participating HTCs. The project is evolving into a platform for data collection for many studies and purposes carried out by the HTRS investigators. For example, currently data forms required by the CDC can be printed out from the platform.

Participants

Participants in the HTRS registry are currently provided with computer hardware and software necessary for data entry on–line, training and technical support necessary for full participation and are offered a stipend for form completion. To obtain additional information and apply for participation, please visit the HTRS Registry Website at www.HTRSregistry.org.

Submit a Request

To submit a request to the HTRS for analysis and utilization of HTRS registry data, please complete and submit this concept sheet.