Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sublingual videomicroscopy, blood sample.
- Who it may be relevant to
- Registry conditions: Von Willebrand Diseases, Glanzmann Thrombasthenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases
Overview
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.
Interventions
- 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
Primary outcome measures
- 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 outcome measures (9)
- Sublingual capillary density [Time frame: At baseline]
- qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy) [Time frame: At baseline and at 3 years]
- delta of Sublingual capillary density increase [Time frame: between inclusion and end of study (at 3 years)]
- ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool) [Time frame: At baseline, at 3 years]
- delta of increase of ISTH-BAT haemorrhagic score [Time frame: between inclusion and end of study (at 3 years)]
- plasma levels of proangiogenic markers [Time frame: at inclusion and end-of-study visits(at 3 years)]
- plasma levels of galectine [Time frame: at inclusion and end-of-study visits(at 3 years)]
- plasma levels of VEGF [Time frame: at inclusion and end-of-study visits(at 3 years)]
- delta of increase in plasma levels of all proangiogenic markers [Time frame: At inclusion and end of study (at 3 years)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHU de Lille — Lille
Identifiers
NCT: NCT04119908 · 2019_05 · 2019-A01601-56