World Bleeding Disorders Registry Pilot Study

Completed

• Conditions: Hemophilia A and B

• Registration Number: NCT02776826
• Lead Sponsor: World Federation of Hemophilia

Brief 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.

Study Timeline

• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Start: 2016-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• Patients of participating Hemophilia Treatment Centres with Hemophilia A or B.
• Ability to provide data in English

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of HTCs which agree to participate in the pilot phase of the WBDR	6 months	This is be measured by the number of HTCs who agree to participate, divided by the number of HTCs invited.
Proportion of participating HTCs who successfully obtain necessary regulatory approval	6 months	This will be measured by the number of HTCs who obtain approval, divided by the number of HTCs who have agreed to participate in the pilot phase of the WBDR.
Proportion of patients who agree to participate in this pilot phase of the WBDR.	6 months	This will be measured by the number of patients who provided consent to participate, divided by the number of patients who were approached to participate.
Proportion of enrolled patients on which data collection and database entry is successful.	6 months	This will be measured by the number of patients on who data is collected and entered successfully into the database, divided by the number of patients who are enrolled in the pilot phase of the WBDR.