Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador

Brief Title

Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador

Official Title

Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador

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.

Study Type

Observational

Primary Outcome

Bleeding Score (BS)

Secondary Outcome

 Associations among BS and female subgroup characteristics and initial laboratory tests.

Condition

Von Willebrand Disease

Study Arms / Comparison Groups

 von Willebrand women

Description:  Referred women who may have von Willebrand Disease

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

March 2013

Completion Date

June 2013

Primary Completion Date

June 2013

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.

Gender

Female

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Jaime M. Moreno A., M.D., M.S., ,

Location Countries

Ecuador

Location Countries

Ecuador

Administrative Informations

NCT ID

NCT01589848

Organization ID

Secondary IDs

UAzuay

Responsible Party

Principal Investigator

Study Sponsor

Universidad del Azuay

Study Sponsor

Jaime M. Moreno A., M.D., M.S., Principal Investigator, Universidad del Azuay (UAzuay)

Verification Date

July 2013