NCT01589848

Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Universidad del Azuay · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

1. Hypothesis a. There are patients with von Willebrand Disease in Cuenca. 2. Primary question a. How many women referred with a history of bleeding may have von Willebrand disease? 3. Secondary 1. Associations between the bleeding score and initial laboratory studies 2. What are the differences on subgroups of enrolled patients with the bleeding score? 4. Ancillary 1. What is the clinical and socio-economic status of women with von Willebrand Disease in Cuenca? 2. What is the clinical and socio-economic status of patients with Hemophilia in Cuenca?

Detailed description

The incidence of hemophilia A is 1 in 10,000 and the one of hemophilia B is 1 in 30,000 live born males. As the most frequent coagulopathy in the world, von Willebrand disease (vWD) can affect 1 in 1000 children of both genders. The prevalence of vWD is 1-2% and it may be as high as 5-15% among women with menorrhagia. So vWD can be present in 1 of every 100 to 500 individuals. A world survey published that Ecuador, with a population of 14,790,608 people, has 238 patients with hemophilia, 45 people with von Willebrand disease (vWD) and 13 patients with other bleeding disorders including rare factor deficiencies and platelet disorders. The Ecuadorian census of 2010 indicates that Cuenca district (canton) has 505,585 inhabitants. According to a local reference, Cuenca has no reports of vWD and it has registered 20-40 patients with hemophilia A and B. However Cuenca may host approximately 10,000 people with vWD because it affects both males and females. One plausible explanation for this lag is that the diagnostic suspicions of vWD had not been proven because of the lack of a special coagulation laboratory in Cuenca that would allow professionals to make a positive diagnosis. This is the first clinical, demographic and socio-economic study of patients registered with hemophilia and of Cuenca women with possible vWD who are referred from dentists and physicians from public and private health centers. The instruments will be validated surveys and screening coagulation studies. As far as we know Ecuador has not published studies on coagulopathies. Our aim is to initiate a process to eventually reach the goal to offer adequate diagnostic and therapeutic interventions to human victims of these diseases, within a program of service, teaching and research.

Conditions

• Von Willebrand Disease
• Hemophilia A
• Hemophilia B

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-05-02
• Last updated: 2013-07-03

Locations

2 sites across 1 country: Ecuador