Combining Registry Data in Haemophilia: TARGET H

Completed

• Conditions: Haemophilia

• Registration Number: NCT03264014
• Lead Sponsor: University of Pretoria

Brief Summary

This is an investigator-initiated, multinational, retrospective, non-interventional pilot study conducted in five haemophilia treatment centres from different geographical regions that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia registry. Data from a randomly selected sample of patients from national or local registries are anonymously collated and analysed.The aims are to determine the feasibility of combining data from national and local registries in countries with developing healthcare systems and to assess how existing registries implemented current recommendations for data collection in terms of available fields and their completion.

Detailed Description

The study is conducted in five haemophilia treatment centres (HTCs) from different geographical regions (Algeria, India, Iran, Malaysia and South Africa) that maintain a local or national haemophilia registry. Data will be collected from 20 randomly selected, active patient records from each participating registry/country. In countries with national registries, data from local registries will not be permitted for inclusion to allow adequate assessment of the possibility of registry harmonisation across various regions. Participating centres will report data as available in the data source without seeking additional information to fill source data gaps at the time of data collection. In addition, each investigator will complete a basic questionnaire on feasibility parameters to confirm the source and accuracy of the data, as well as challenges experienced during data collection. Analysed parameters will be grouped into three categories: sociodemographic, disease, and treatment and disease outcome parameters. Feasibility assessment will be performed for all study variables and the percentage availability of each study variable recorded in the participating registries wii be determined, as well as the proportion of missing data for existing variables.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-09
• Study Completion: 2015-09-30
• Status Verified: 2017-08
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-24
• Last Update Submitted: 2017-08-24
• Study First Posted: 2017-08-28
• Last Update Posted: 2017-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• male
• diagnosis of haemophilia A or B
• with or without inhibitors
• no other inherited bleeding disorder
• active patient record
• willing and able to provide written consent

Exclusion Criteria

• unwilling or unable to provide written consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemophilia registry data	May to September 2015	sosiodemographic parameters, disease parameters and treatment and disease outcome parameters