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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 September 2023 |
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Main ID: |
NCT04119908 |
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Date of registration:
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07/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases
VIDEO-BLEED |
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Scientific title:
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Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases |
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Date of first enrolment:
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May 24, 2023 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04119908 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Antoine Rauch, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Lille |
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Name:
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Antoine Rauch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Antoine Rauch, MD,PhD |
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Address:
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Telephone:
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3 20445962 (poste 29673) |
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Email:
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antoine.rauch@chru-lille.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Von Willebrand Diseases
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Glanzmann Thrombasthenia
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Intervention(s)
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Device: Sublingual videomicroscopy
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Biological: blood sample
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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plasma levels of galectine
[Time Frame: at inclusion and end-of-study visits(at 3 years)]
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Sublingual capillary density
[Time Frame: At baseline]
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ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool)
[Time Frame: At baseline, at 3 years]
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delta of Sublingual capillary density increase
[Time Frame: between inclusion and end of study (at 3 years)]
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qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)
[Time Frame: At baseline and at 3 years]
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delta of increase of ISTH-BAT haemorrhagic score
[Time Frame: between inclusion and end of study (at 3 years)]
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plasma levels of VEGF
[Time Frame: at inclusion and end-of-study visits(at 3 years)]
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delta of increase in plasma levels of all proangiogenic markers
[Time Frame: At inclusion and end of study (at 3 years)]
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plasma levels of proangiogenic markers
[Time Frame: at inclusion and end-of-study visits(at 3 years)]
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Secondary ID(s)
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2019-A01601-56
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2019_05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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