NCT02776826

World Bleeding Disorders Registry Pilot Study

World Bleeding Disorders Registry Pilot Phase

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 356 (actual)
• Sponsor: World Federation of Hemophilia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The World Federation of Hemophilia (WFH) is conducting the pilot phase of an international, observational, World Bleeding Disorders Registry (WBDR). This pilot phase will assess the feasibility of conducting an expanded WBDR to more centres with a more comprehensive case report form, around the world.

Detailed description

The pilot phase of the WBDR is an observational disease registry of patients with hemophilia. Forty hemophilia treatment centres (HTCs), of varying levels of economic development (emerging, mid-level and established), that have data entry capabilities and the ability to obtain the required data on patients in English, were invited to participate in the pilot phase. Participating HTCs will complete a Minimal Data Set (MDS) of data on approximately 10 patients each. A series of performance indicators have been identified by the Steering committee and will be used to assess the feasibility of expanding the pilot phase to the WBDR. The performance indicators include: proportion of HTCs invited that are willing to participate; proportion of participating HTCs who successfully obtain necessary regulatory approvals; proportion of patients approached who consent to participate; proportion of enrolled patients on which data collection and database entry is successful.

Conditions

• Hemophilia A and B

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-05-18
• Last updated: 2017-10-31