Von Willebrand Diseases Clinical Trial
— VIDEO-BLEEDOfficial title:
Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases
In Willebrand disease, there is currently no test available to identify non-invasively patients with a high risk of bleeding from angiodysplasias The study propose to use a sublingual capillary bed analysis by video-microscopy, a sensitive, reproducible and non-invasive technique, to assess whether sublingual capillary density is predictive of hemorrhagic risk for patients with von Willebrand disease.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | May 24, 2028 |
Est. primary completion date | May 24, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient with a significant form of von Willebrand disease (according to the inclusion criteria of the Willebrand Disease French Reference Center), a Glanzmann Thrombasthenia, a moderate to severe Haemophilia A or a woman carrying the hemophilia gene - Social insured patient Exclusion Criteria: - Minor patient - Refusal of consent - Person benefiting from a system of legal protection - Pregnant patient |
Country | Name | City | State |
---|---|---|---|
France | CHU de Lille | Lille | Nord |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage" | at 3 years | ||
Secondary | Sublingual capillary density | To compare the sublingual capillary density of patients with von Willebrand disease to that of 3 other groups of patients:
with a severe form of hemophilia A with a moderate form of hemophilia A women carrying the hemophilia gene |
At baseline | |
Secondary | qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy) | presence or absence of qualitative abnormalities | At baseline and at 3 years | |
Secondary | delta of Sublingual capillary density increase | between inclusion and end of study (at 3 years) | ||
Secondary | ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool) | ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30 | At baseline, at 3 years | |
Secondary | delta of increase of ISTH-BAT haemorrhagic score | ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30 | between inclusion and end of study (at 3 years) | |
Secondary | plasma levels of proangiogenic markers | dosage of angiopoietin-1, angiopoetin-2 (pg/mL) measured by ELISA | at inclusion and end-of-study visits(at 3 years) | |
Secondary | plasma levels of galectine | galectin-1 and galectin-3 measured by ELISA | at inclusion and end-of-study visits(at 3 years) | |
Secondary | plasma levels of VEGF | Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood measured by ELISA | at inclusion and end-of-study visits(at 3 years) | |
Secondary | delta of increase in plasma levels of all proangiogenic markers | At inclusion and end of study (at 3 years) |
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