Latin-American Von Willebrand Disease Registry

NCT ID: NCT04279717

Last Updated: 2020-02-21

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

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-29

Study Completion Date

2022-12-31

Brief Summary

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Establish a Latin-American network of centers and professionals with the aim of:

* To register VWD patients in retrospective/prospective study, using a database, available online, common to all
* To register the bleeding history, the treatment and the events of VWD patients in the region
* To investigate the influence of VWD on quality of life

Detailed Description

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von Willebrand disease (VWD) is the most common autosomal bleeding disorder, mostly inherited as dominant trait. VWD is due to deficiency/abnormality of von Willebrand factor (VWF). The prevalence of VWD is unknown, but estimated as 0.1% to 1% of the general population. Although the autosomal inheritance pattern would suggest an equal distribution of male and female patients, the disease is diagnosed in more females because of female-specific hemostatic challenges: menses, ovulation, pregnancy and childbirth. Diagnosis of VWD is made by assessing personal and family history of bleeding, physical examination and completed with specific laboratory tests.

There is limited information on the epidemiology of VWD in developing countries. Some countries in Latin America have registries of severe disease that, although it is the rarest form, carries the highest costs for regional health systems. So that the prevalence of clinical symptoms and laboratory features of the disease as well as the management of the disease in Latin America is unknown.

The present project aims to establish a network of centers and professionals with the objective to register and investigate all patients with VWD in Latin America, using a database available online common to all, to gain understanding about phenotype, genotype and management of VWD in the region.

Conditions

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Von Willebrand Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects with von Willbrand Disease Acquired

Observation

Intervention Type OTHER

No interventions planned: treatment of patients at the discretion of the treating/responsible physician

Subjects with von Willbrand Disease Congenital

Observation

Intervention Type OTHER

No interventions planned: treatment of patients at the discretion of the treating/responsible physician

Interventions

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Observation

No interventions planned: treatment of patients at the discretion of the treating/responsible physician

Intervention Type OTHER

Observation

No interventions planned: treatment of patients at the discretion of the treating/responsible physician

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Historically lowest VWF:Ag and/or VWF:RCo and/or VWF:CB \< 0.50 IU/ml and/or FVIII:C \< 0.50 IU/ml
* All types of VWD
* All ages

Exclusion Criteria

* Patient without consent to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academia Nacional de Medicina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Analia Sanchez Luceros, PhD, MD

Role: CONTACT

+5491152203235

Analia Kinen

Role: CONTACT

Other Identifiers

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Protocol_3081

Identifier Type: -

Identifier Source: org_study_id

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