CClinicalTrials.gg
CompletedNCT03264014TARGET-HUpdated Aug 28, 2017

Combining Registry Data in Haemophilia: TARGET H

An observational study in Haemophilia, sponsored by University of Pretoria. Completed. Open to male participants. Per ClinicalTrials.gov, last updated 2017-08-28.

Sponsored by University of Pretoria · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
100
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Haemophilia

Browse trials for

03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Registry records of 100 randomly selected haemophilia patients

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

Exclusion Criteria:

  • unwilling or unable to provide written consent
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Haemophilia registry data

    sosiodemographic parameters, disease parameters and treatment and disease outcome parameters

    Time frame: May to September 2015

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03264014
Lead sponsor
University of Pretoria
Collaborators
Novo Nordisk A/S, Medical Research Council, South Africa
Responsible party
Joachim Potgieter (Dr., University of Pretoria) — Principal investigator
First posted
Aug 28, 2017
Start date
May 2015
Primary completion
Sep 2015
Completion
Sep 30, 2015
Last update
Aug 28, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion