Clinical trial NCT01589848: Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador
Official title: Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Von Willebrand Disease
Hemophilia A
Hemophilia B
Keywords: vWD
Lead sponsor: Universidad del Azuay
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target population: all women from Cuenca district with a hemorrhage history.

Accessible population: Those women referred from professionals with an initial hemorrhage history, who comply with the inclusion criteria and who sign the informed consert form.

Sample population: First comers referred with a hemorrhage history until fulfilling the projected sample size. This non-probabilistic purposive sample will be used because it has been reported that it could represent the target population.

\*2010 Ecuadorian census: 131.163 women ages 18 to 50 years, at Cuenca district.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects living at urban and rural parishes from Cuenca district.
* Subjects referred from professionals of public and private health services, who have filled the initial hemorrhage survey.
* Must be referred women who sign the informed consent form.
* Patients who answer the standardized bleeding score questionnaire (BS).
* Patients who answer the quality of life questionnaire (SF-12).
* Patients who answer the socio-economic survey.
* Patients who accept to provide a venous blood sample for the initial laboratory tests.

Exclusion Criteria:

* Women with organic or hormonal bleeding etiologies.
* Patients taking medicines which may affect the coagulation cascade or the number or function of platelets.
* Those women who otherwise do not comply with the inclusion criteria.

Primary outcomes:
measure: Bleeding Score (BS)
timeFrame: 1 week
Secondary outcomes:
measure: Associations among BS and female subgroup characteristics and initial laboratory tests.
timeFrame: 1 week
Other outcomes:
Locations:
city: Cuenca
country: Ecuador
facility: UAzuay
state: Azuay
city: Cuenca
country: Ecuador
facility: Universidad del Azuay (UDA)
state: Azuay
Study officials:
affiliation: Universidad del Azuay (UAzuay)
name: Jaime M. Moreno A., M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Azuay (UAzuay)
name: Jacinto Guillen G., Eng., M.S.
role: STUDY_CHAIR
affiliation: Universidad del Azuay (UAzuay)
name: Rodrigo Cueva M., Econ., M.S.
role: STUDY_DIRECTOR
References: