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Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases

ConditionsVon Willebrand DiseasesGlanzmann Thrombasthenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Minor patient

Refusal of consent

Person benefiting from a system of legal protection

Pregnant patient

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sublingual videomicroscopy

    Device

    Measurement of sublingual capillary density by video microscopy

  • blood sample

    Biological/Vaccine

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Patients with haemorrhagic diseaseExperimental treatment 2 interventions
Group B: Control groupOther 1 intervention

Trial outcomes

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

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

Time frame
At baseline
2

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

presence or absence of qualitative abnormalities

Time frame
At baseline and at 3 years
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)

ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30

Time frame
At baseline, at 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Source ClinicalTrials.gov
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