Von Willebrand DiseasesVIDEO-BLEEDNCT04119908
Videomicroscopy for the Prediction of Bleeding in Constitutional Haemorrhagic Diseases
A study testing Sublingual videomicroscopy and blood sample in people with Von Willebrand Diseases and Glanzmann Thrombasthenia, run by University Hospital, Lille at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Von Willebrand Diseases, Glanzmann Thrombasthenia
- What is being tested?
- Sublingual videomicroscopy and blood sample
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2023to 24 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minor patient
- Refusal of consent
- Person benefiting from a system of legal protection
- Pregnant patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille, Nord, 59000
Antoine Rauch, MD
Antoine Rauch, md
About this study
Official title: Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other 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.
- Conditions
- Von Willebrand Diseases, Glanzmann Thrombasthenia
- Being tested
- Sublingual videomicroscopy, blood sample
- Keywords
- constitutional haemorrhagic diseases, Videomicroscopy, prediction, bleeding, Videomicroscopy, prediction, bleeding
- Medical subject headings
- von Willebrand Diseases, Thrombasthenia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual videomicroscopyDevice
Measurement of sublingual capillary density by video microscopy
blood sampleBiological
Collection of citrate tubes of 5 mL at baseline and at 36 months
| Study group | Role | What they receive |
|---|---|---|
| Patients with haemorrhagic disease | Experimental | Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia Receives: Device: Sublingual videomicroscopy; Biological: blood sample |
| Control group | Other | Patients with moderate or severe hemophilia A or women carrying the hemophilia gene Receives: Device: Sublingual videomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage"
Measured: at 3 years
Secondary outcomes (9)
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
Measured: At baseline
qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)
presence or absence of qualitative abnormalities
Measured: At baseline and at 3 years
delta of Sublingual capillary density increase
Measured: between inclusion and end of study (at 3 years)
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
Measured: At baseline, at 3 years
delta of increase of ISTH-BAT haemorrhagic score
ISTH-BAT is a questionnaire minimum score ranges from 0 to 10 whereas maximum score ranges from 20 to 30
Measured: between inclusion and end of study (at 3 years)
plasma levels of proangiogenic markers
dosage of angiopoietin-1, angiopoetin-2 (pg/mL) measured by ELISA
Measured: at inclusion and end-of-study visits(at 3 years)
plasma levels of galectine
galectin-1 and galectin-3 measured by ELISA
Measured: at inclusion and end-of-study visits(at 3 years)
plasma levels of VEGF
Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood measured by ELISA
Measured: at inclusion and end-of-study visits(at 3 years)
delta of increase in plasma levels of all proangiogenic markers
Measured: At inclusion and end of study (at 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start24 May 2023
- Primary completion24 May 2028 (estimated)
- Study completion24 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Rauch, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119908
- Sponsor's protocol ID
- 2019_05
- Other IDs
- 2019-A01601-56
- Acronym
- VIDEO-BLEED
- Status last verified
- May 2026
- First submitted
- 7 Oct 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases
- ClinicalTrials.gov ID
- NCT04119908
- Acronym / sponsor ID
- VIDEO-BLEED / 2019_05
- Conditions
- Von Willebrand Diseases, Glanzmann Thrombasthenia
- Keywords
- constitutional haemorrhagic diseases, Videomicroscopy, prediction, bleeding, Videomicroscopy, prediction, bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 24 May 2028 (estimated)
- Study completion
- 24 May 2028 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with haemorrhagic disease | Experimental | Device: Sublingual videomicroscopy, Biological: blood samplePatients with von Willebrand disease or Patients with Glanzmann Thrombasthenia |
| Control group | Other | Device: Sublingual videomicroscopyPatients with moderate or severe hemophilia A or women carrying the hemophilia gene |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Minor patient
- Refusal of consent
- Person benefiting from a system of legal protection
- Pregnant patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual videomicroscopyMeasurement of sublingual capillary density by video microscopy | Device | Control group, Patients with haemorrhagic disease |
| blood sampleCollection of citrate tubes of 5 mL at baseline and at 36 months | Biological | Patients with haemorrhagic disease |
Primary outcome
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
9 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Related trials for Von Willebrand Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
RecruitingPhase 3
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Von Willebrand Diseases
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease
Von Willebrand Disease, Type 3
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine Rauch, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sublingual videomicroscopy and blood sample in people with Von Willebrand Diseases and Glanzmann Thrombasthenia, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Rauch, MD,PhD (3 20445962 (poste 29673) ext. +33, antoine.rauch@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.