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Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador

Information source: Universidad del Azuay
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Von Willebrand Disease; Hemophilia A; Hemophilia B

Phase: N/A

Status: Completed

Sponsored by: Universidad del Azuay

Official(s) and/or principal investigator(s):
Jaime M. Moreno A., M.D., M.S., Principal Investigator, Affiliation: Universidad del Azuay (UAzuay)
Jacinto Guillen G., Eng., M.S., Study Chair, Affiliation: Universidad del Azuay (UAzuay)
Rodrigo Cueva M., Econ., M.S., Study Director, Affiliation: Universidad del Azuay (UAzuay)

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?

Clinical Details

Official title: Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador

Study design: N/A

Primary outcome: Bleeding Score (BS)

Secondary outcome: Associations among BS and female subgroup characteristics and initial laboratory tests.

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

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Locations and Contacts

UAzuay, Cuenca, Azuay 0001, Ecuador

Universidad del Azuay (UDA), Cuenca, Azuay 0001, Ecuador

Additional Information

Starting date: March 2013
Last updated: July 2, 2013

Page last updated: August 20, 2015

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