World Bleeding Disorders Registry Pilot Study

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.

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Key information

Conditions

Hemophilia A and B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

Primary outcomes

Proportion of HTCs which agree to participate in the pilot phase of the WBDR

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

World Federation of Hemophilia

Other

Registry information

Official study title

World Bleeding Disorders Registry Pilot Phase

Acronym: WBDR

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: May 18, 2016
Registry last updated: Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed