World Bleeding Disorders Registry Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

356 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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

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Hemophilia A and B

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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WBDR Pilot Phase

Identifier Type: -

Identifier Source: org_study_id