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

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.

Study Overview

• Status: Recruiting
• Conditions: Glanzmann Thrombasthenia; Von Willebrand Diseases
• Intervention / Treatment: Device: Sublingual videomicroscopy; Biological: blood sample

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine Rauch, MD,PhD; Phone Number: +33 3 20445962 (poste 29673); Email: antoine.rauch@chru-lille.fr

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59000
      • Recruiting
      • CHU de Lille
      • Principal Investigator: Antoine RAUCH, MD
      • Contact: Antoine Rauch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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: with a severe form of hemophilia A; with a moderate form of hemophilia A; women carrying the hemophilia gene	At baseline
qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)	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)

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Antoine Rauch, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): May 24, 2028
• Study Completion (Estimated): May 24, 2028

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: bleeding; prediction; constitutional haemorrhagic diseases, Videomicroscopy, prediction, bleeding; Videomicroscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Blood Platelet Disorders; Hemorrhage; Thrombasthenia; Von Willebrand Diseases
• Other Study ID Numbers: 2019_05; 2019-A01601-56 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No