Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador (VWD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01589848|
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : July 3, 2013
a. There are patients with von Willebrand Disease in Cuenca.
a. How many women referred with a history of bleeding may have von Willebrand disease?
- Associations between the bleeding score and initial laboratory studies
- What are the differences on subgroups of enrolled patients with the bleeding score?
- What is the clinical and socio-economic status of women with von Willebrand Disease in Cuenca?
- What is the clinical and socio-economic status of patients with Hemophilia in Cuenca?
|Condition or disease|
|Von Willebrand Disease Hemophilia A Hemophilia B|
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|
|Actual Enrollment :||81 participants|
|Official Title:||Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador|
|Study Start Date :||March 2013|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
von Willebrand women
Referred women who may have von Willebrand Disease
- Bleeding Score (BS) [ Time Frame: 1 week ]
As an adequate bleeding history is fundamental, the Condensed MCMDM-1 Bleeding Questionnaire will be used. Its bleeding score (BS) has a sensitivity of 100%, specificity 87%, positive predictive value 0.2 and negative predictive value 1.0. There was a signifficant difference of BS between the subtypes of vWD: with type 3 >>type 2 >>type 1 vWD (Anova P <0.001).
AS the BS is an index of ordinal values, medians and the Mann-Whitney non-parametric ranksum test will be used, to study the bleeding score (BS) differences among subgroups of enrolled women.
- Associations among BS and female subgroup characteristics and initial laboratory tests. [ Time Frame: 1 week ]
As bleeding may tend to associate in subjects, i.e. epistaxis and menorrhagia, a logistic (log-linear) model will be used. As bleeding can also ocur independently, symptoms will be coded for an adjusted covariate analysis.
To study the relationships among the BS and the quantitative laboratory results, the BS will be divided in quintiles, and an adjusted multiple regression model will be used. Likelihood ratios (LR) for values of BS, with a prevalence of 5% and ROC curves will be applied. According to Tosetto et.al. laboratory data will be expressed in categorical and quantitative scales.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589848
|Cuenca, Azuay, Ecuador, 0001|
|Universidad del Azuay (UDA)|
|Cuenca, Azuay, Ecuador, 0001|
|Principal Investigator:||Jaime M. Moreno A., M.D., M.S.||Universidad del Azuay (UAzuay)|
|Study Chair:||Jacinto Guillen G., Eng., M.S.||Universidad del Azuay (UAzuay)|
|Study Director:||Rodrigo Cueva M., Econ., M.S.||Universidad del Azuay (UAzuay)|