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

University Hospital, Lille

Status: Enrolling

Conditions: Von Willebrand Diseases; Glanzmann Thrombasthenia

Treatments: Biological: blood sample; Device: Sublingual videomicroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04119908

2019-A01601-56 (Other Identifier)

2019_05

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Patients with haemorrhagic disease

Experimental group

Description:

Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia

Treatment:

Device: Sublingual videomicroscopy

Biological: blood sample

Control group

Other group

Description:

Patients with moderate or severe hemophilia A or women carrying the hemophilia gene

Treatment:

Device: Sublingual videomicroscopy