Von Willebrand DiseasesINDONESIANCT03773159
Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
An observational study of Von Willebrand Diseases and Major Constitutional Thrombopathy, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Von Willebrand Diseases, Major Constitutional Thrombopathy, Patient on Antiplatelet Drugs
- What is being tested?
- Blood sampling
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- 6 May 2019to May 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with von Willebrand disease or major constitutional thrombopathy or patient on antiplatelet drugs
Who may be able to join
- person who has given oral consent
- adult
- blood donor at EFS Bourgogne Franche-Comté
- or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
- or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital
Who cannot join
- a person who is not affiliated to or not a beneficiary of national health insurance
- person subject to court-ordered protection (curatorship, guardianship)
- pregnant, parturient or breastfeeding woman
- a person who is unable to consent
- person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU de Besançon
Besançon
Guillaume MOUREY, 03 81 61 56 15, guillaume.mourey@efs.sante.fr
- Recruiting
CHU Dijon Bourgogne
Dijon
Emmanuel De Maistre, 03 80 29 32 57, emmanuel.demaistre@chu-dijon.fr
About this study
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.
An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).
Read more
The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.
Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).
- Being tested
- Blood sampling
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
4 citrated/PPACK tubes and 1 EDTA tube maximum
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs Receives: Biological: Blood sampling | |
| Controls | Blood donors at the French blood establishment in Burgundy Franche-Comté Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability and reproducibility of the result in controls
Measured: Baseline
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start6 May 2019
- Primary completionMay 2028 (estimated)
- Study completionMay 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773159
- Sponsor's protocol ID
- De MAISTRE ANR 2017
- Acronym
- INDONESIA
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2018
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions
- ClinicalTrials.gov ID
- NCT03773159
- Acronym / sponsor ID
- INDONESIA / De MAISTRE ANR 2017
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 12 Dec 2018 (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.
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.
An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).
The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.
Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: Blood samplingPatients with von Willebrand disease or major constitutional thrombopathy or patients on antiplatelet drugs |
| Controls | – | Biological: Blood samplingBlood donors at the French blood establishment in Burgundy Franche-Comté |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with von Willebrand disease or major constitutional thrombopathy or patient on antiplatelet drugs
Key inclusion criteria (5 listed)
- person who has given oral consent
- adult
- blood donor at EFS Bourgogne Franche-Comté
- or patient with von Willebrand disease or major constitutional thrombopathy followed by the Resource and Competence Centre (CRC) - Constitutional Hemorrhagic Diseases of Dijon or Besançon
- or patient on antiplatelet drugs consulting for thrombosis at the Dijon Bourgogne or Besançon Hospital
Key exclusion criteria (5 listed)
- a person who is not affiliated to or not a beneficiary of national health insurance
- person subject to court-ordered protection (curatorship, guardianship)
- pregnant, parturient or breastfeeding woman
- a person who is unable to consent
- person on anti-inflammatory treatment and serotonin reuptake inhibitor antidepressants (platelet function disorders)
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 |
|---|---|---|
| Blood sampling4 citrated/PPACK tubes and 1 EDTA tube maximum | Biological | Controls, Patients |
Primary outcome
Repeatability and reproducibility of the result in controls
Time frame: Baseline
Detection of antiplatelet or von Willebrand factor deficiency/major constitutional thrombopathy
Time frame: Baseline
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 2 Apr 2026.
Related trials for Von Willebrand Diseases
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)
RecruitingObservational study
Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation
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
RecruitingPhase 3
Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)
Von Willebrand Disease (VWD)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Diseases and Major Constitutional Thrombopathy, run by Centre Hospitalier Universitaire Dijon at 2 sites 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 5 inclusion and 5 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Emmanuel De Maistre (03 81 61 56 15, emmanuel.demaistre@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability and reproducibility of the result in controls (time frame: Baseline). The study lists 2 primary outcomes in all. 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 2 Apr 2026.