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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01601-56 | Other Identifier | ID-RCB number,ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haemorrhagic disease | Experimental | Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia |
|
| Control group | Other | Patients with moderate or severe hemophilia A or women carrying the hemophilia gene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual videomicroscopy | Device | Measurement of sublingual capillary density by video microscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sublingual capillary density | To compare the sublingual capillary density of patients with von Willebrand disease to that of 3 other groups of patients:
| At baseline |
| qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine Rauch, MD,PhD | Contact | 3 20445962 (poste 29673) | +33 | antoine.rauch@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine Rauch, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille | Recruiting | Lille | Nord | 59000 | France |
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| ID | Term |
|---|---|
| D014842 | von Willebrand Diseases |
| D013915 | Thrombasthenia |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| blood sample | Biological | Collection of citrate tubes of 5 mL at baseline and at 36 months |
|
presence or absence of qualitative abnormalities |
| At baseline and at 3 years |
| delta of Sublingual capillary density increase | between inclusion and end of study (at 3 years) |
| 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 |
| 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) |
| 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) |
| plasma levels of galectine | galectin-1 and galectin-3 measured by ELISA | at inclusion and end-of-study visits(at 3 years) |
| 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) |
| delta of increase in plasma levels of all proangiogenic markers | At inclusion and end of study (at 3 years) |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |