World Bleeding Disorders Registry Pilot Study

Hemophilia A and B Clinical Trial

— WBDR  

Official title:

World Bleeding Disorders Registry Pilot Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776826
• Other study ID #: WBDR Pilot Phase
• Status: Completed
• Phase: N/A
• First received: May 11, 2016
• Last updated: October 27, 2017
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: World Federation of Hemophilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients of participating Hemophilia Treatment Centres with Hemophilia A or B.

• Ability to provide data in English

Exclusion Criteria:

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemophilia A
• Hemophilia A and B
• Hemostatic Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
World Federation of Hemophilia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of HTCs which agree to participate in the pilot phase of the WBDR	This is be measured by the number of HTCs who agree to participate, divided by the number of HTCs invited.	6 months
Primary	Proportion of participating HTCs who successfully obtain necessary regulatory approval	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.	6 months
Primary	Proportion of patients who agree to participate in this pilot phase of the WBDR.	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.	6 months
Primary	Proportion of enrolled patients on which data collection and database entry is successful.	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.	6 months