Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04119908

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

Led by University Hospital, Lille · Updated on 2026-05-20

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether sublingual videomicroscopy, a non-invasive and sensitive technique that analyzes capillary density under the tongue, can predict bleeding risk in patients with von Willebrand disease and other congenital bleeding disorders such as Glanzmann Thrombasthenia and moderate to severe Hemophilia A, including women carrying the hemophilia gene. This study addresses the current lack of non-invasive tests to identify patients at high risk of bleeding from angiodysplasias. Participants will undergo sublingual videomicroscopy to measure capillary density, alongside blood sample collection at the start and after 36 months. The study includes two groups: patients with hemorrhagic diseases and a control group. The primary focus is to assess the predictive value of sublingual capillary density for significant bleeding events over three years. During the study, participants will have baseline and three-year evaluations including capillary density, qualitative capillary abnormalities, bleeding scores using the ISTH-BAT tool, and plasma levels of proangiogenic markers such as galectine and VEGF. The main outcome is the correlation between capillary density and bleeding events within three years. The study spans three years, monitoring participants’ bleeding risk and related biological markers over this period.

CONDITIONS

Brief Title

Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient with a significant form of von Willebrand disease, Glanzmann Thrombasthenia, moderate to severe Haemophilia A, or a woman carrying the hemophilia gene
  • Social insured patient
Not Eligible

You will not qualify if you...

  • Minor patient
  • Refusal of consent
  • Person benefiting from a system of legal protection
  • Pregnant patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At baseline and over 3 years

Participants undergo sublingual videomicroscopy to measure capillary density and blood samples are collected to assess biomarkers related to bleeding disorders.

2 visits (baseline and at 3 years)

Long-term Monitoring

Duration - 3 years

Participants are monitored for clinically significant hemorrhagic events and changes in bleeding assessment scores and biomarkers during the 3-year study period.

Follow-up visits at baseline and at 3 years

Trial Site Locations

Total: 1 location

1

CHU de Lille

Lille, Nord, France, 59000

Actively Recruiting

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Research Team

A

Antoine Rauch, MD,PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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