Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

Von Willebrand Diseases Clinical Trial

— VIDEO-BLEED  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Glanzmann Thrombasthenia
• Hemorrhage
• Von Willebrand Diseases

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)