VIDEO-BLEED: Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

Sponsor

University Hospital, Lille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04119908

Collaborator

(none)

400

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Von Willebrand Diseases Glanzmann Thrombasthenia	Device: Sublingual videomicroscopy Biological: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with haemorrhagic disease Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia	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
Other: Control group Patients with moderate or severe hemophilia A or women carrying the hemophilia gene	Device: Sublingual videomicroscopy Measurement of sublingual capillary density by video microscopy

Arm

Intervention/Treatment

Experimental: Patients with haemorrhagic disease

Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia

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

Other: Control group

Patients with moderate or severe hemophilia A or women carrying the hemophilia gene

Device: Sublingual videomicroscopy

Measurement of sublingual capillary density by video microscopy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Sublingual capillary density [At baseline]
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
qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy) [At baseline and at 3 years]
presence or absence of qualitative abnormalities
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) [At baseline, at 3 years]
ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30
delta of increase of ISTH-BAT haemorrhagic score [between inclusion and end of study (at 3 years)]
ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30
plasma levels of proangiogenic markers [at inclusion and end-of-study visits(at 3 years)]
dosage of angiopoietin-1, angiopoetin-2 (pg/mL) measured by ELISA
plasma levels of galectine [at inclusion and end-of-study visits(at 3 years)]
galectin-1 and galectin-3 measured by ELISA
plasma levels of VEGF [at inclusion and end-of-study visits(at 3 years)]
Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood measured by ELISA
delta of increase in plasma levels of all proangiogenic markers [At inclusion and end of study (at 3 years)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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