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Trial record 52 of 456 for:    Inherited Bleeding Disorder

World Bleeding Disorders Registry Pilot Study (WBDR)

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ClinicalTrials.gov Identifier: NCT02776826
Recruitment Status : Completed
First Posted : May 18, 2016
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
World Federation of Hemophilia

Brief 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.

Condition or disease
Hemophilia A and B

Detailed 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 356 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Target Follow-Up Duration: 5 Months
Official Title: World Bleeding Disorders Registry Pilot Phase
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Hemophilia A or B, who are patients of participating Hemophilia Treatment Centres.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Additional Information:

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Responsible Party: World Federation of Hemophilia
ClinicalTrials.gov Identifier: NCT02776826     History of Changes
Other Study ID Numbers: WBDR Pilot Phase
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases