Hemophilia A Clinical Trial
Official title:
Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador
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?
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.
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