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NCT Number: NCT04119908

Videomicroscopy for the Prediction of Bleeding in 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.

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Key information

Conditions

Von Willebrand Diseases Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glanzmann Thrombasthenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombasthenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Lille

Lille, Nord, 59000, France

Location status: Recruiting

Location contact

Antoine Rauch, MD

CONTACT

Antoine Rauch, md

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sublingual videomicroscopy

Device

Measurement of sublingual capillary density by video microscopy

Blood sample

Biological

Collection of citrate tubes of 5 mL at baseline and at 36 months

Primary outcomes

  1. area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage"

    Time frame: at 3 years

Secondary outcomes

  1. Sublingual capillary density

    Time frame: 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

  2. qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)

    Time frame: At baseline and at 3 years

    presence or absence of qualitative abnormalities

  3. delta of Sublingual capillary density increase

    Time frame: between inclusion and end of study (at 3 years)

  4. ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool)

    Time frame: 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

  5. delta of increase of ISTH-BAT haemorrhagic score

    Time frame: 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

  6. plasma levels of proangiogenic markers

    Time frame: at inclusion and end-of-study visits(at 3 years)

    dosage of angiopoietin-1, angiopoetin-2 (pg/mL) measured by ELISA

  7. plasma levels of galectine

    Time frame: at inclusion and end-of-study visits(at 3 years)

    galectin-1 and galectin-3 measured by ELISA

  8. plasma levels of VEGF

    Time frame: at inclusion and end-of-study visits(at 3 years)

    Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood measured by ELISA

  9. delta of increase in plasma levels of all proangiogenic markers

    Time frame: At inclusion and end of study (at 3 years)

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Rauch, MD,PhD

CONTACT

[email protected]

3 20445962 (poste 29673) ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: VIDEO-BLEED

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 9, 2019
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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