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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04119908
Other study ID # 2019_05
Secondary ID 2019-A01601-56
Status Recruiting
Phase N/A
First received
Last updated
Start date May 24, 2023
Est. completion date May 24, 2028

Study information

Verified date September 2023
Source University Hospital, Lille
Contact Antoine Rauch, MD,PhD
Phone 3 20445962 (poste 29673)
Email antoine.rauch@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Sublingual videomicroscopy
Measurement of sublingual capillary density by video microscopy
Biological:
blood sample
Collection of citrate tubes of 5 mL at baseline and at 36 months

Locations

Country Name City State
France CHU de Lille Lille Nord

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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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