HemostasisBAPAPFANCT06753838
Choice of Anticoagulant for Primary Hemostasis Studies With PFA200® (Platelet Function Analyser)
An observational study of Hemostasis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The PFA (platelet function analysis) test is prescribed for the exploration of primary hemostasis and the study of platelet-willebrand factor interaction. It is performed using citrated blood, with technical difficulties and frequent alarms that may be linked to the choice of anticoagulant (citrate). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis
- What is being tested?
- Sampling of 3 additional BAPA tubes
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2025to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring a PFA test
Who may be able to join
- Person having given their non-opposition
- Person of legal age
- Person receiving a haemostasis consultation at the haemophilia and haemorrhagic diseases treatment center followed by a blood sample with a PFA test prescribed by the doctor (the test is not added for the study).
Who cannot join
- persons under legal protection (curatorship, guardianship)
- persons subject to a court protection order
- pregnant, parturient or breast-feeding women
- adult incapable or unable to give consent
- minor
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 Dijon Bourgogne
Dijon, 21000
Emmanuel De Maistre, 03 80 29 32 57, emmanuel.demaistre@chu-dijon.fr
About this study
The PFA (platelet function analysis) test is prescribed for the exploration of primary hemostasis and the study of platelet-willebrand factor interaction. It is performed using citrated blood, with technical difficulties and frequent alarms that may be linked to the choice of anticoagulant (citrate). It is proposed to compare the results obtained with a conventional citrate tube and a BAPA tube, which is an anticoagulant used in clinical research and which blocks coagulation by another mechanism that would have less impact on blood platelets.
- Conditions
- Hemostasis
- Being tested
- Sampling of 3 additional BAPA tubes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of 3 additional BAPA tubesBiological
the 3 additional tubes will be taken at the same time as the blood sample taken for the routine PFA test
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring a PFA test for the diagnosis of Willebrand disease | Not described Receives: Biological: Sampling of 3 additional BAPA tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion time measurement
Measurement of the occlusion times of the 2 cartridges (collagen/ADP and collagen/epinephrine) with the classic 0.109M citrate tube and the BAPA tube, with any PLC alarms and observation of the stained blood smears.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start21 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT06753838
- Sponsor's protocol ID
- DE MAISTRE 2024
- Acronym
- BAPAPFA
- Status last verified
- Sep 2025
- First submitted
- 23 Dec 2024
- Last updated
- 29 Sep 2025
- 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Anticoagulant for Primary Hemostasis Studies With PFA200® (Platelet Function Analyser)
- ClinicalTrials.gov ID
- NCT06753838
- Acronym / sponsor ID
- BAPAPFA / DE MAISTRE 2024
- Conditions
- Hemostasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
The PFA (platelet function analysis) test is prescribed for the exploration of primary hemostasis and the study of platelet-willebrand factor interaction. It is performed using citrated blood, with technical difficulties and frequent alarms that may be linked to the choice of anticoagulant (citrate). It is proposed to compare the results obtained with a conventional citrate tube and a BAPA tube, which is an anticoagulant used in clinical research and which blocks coagulation by another mechanism that would have less impact on blood platelets.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring a PFA test for the diagnosis of Willebrand disease | – | Biological: Sampling of 3 additional BAPA tubes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring a PFA test
Key inclusion criteria (3 listed)
- Person having given their non-opposition
- Person of legal age
- Person receiving a haemostasis consultation at the haemophilia and haemorrhagic diseases treatment center followed by a blood sample with a PFA test prescribed by the doctor (the test is not added for the study).
Key exclusion criteria (5 listed)
- persons under legal protection (curatorship, guardianship)
- persons subject to a court protection order
- pregnant, parturient or breast-feeding women
- adult incapable or unable to give consent
- minor
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 |
|---|---|---|
| Sampling of 3 additional BAPA tubesthe 3 additional tubes will be taken at the same time as the blood sample taken for the routine PFA test | Biological | Patients requiring a PFA test for the diagnosis of Willebrand disease |
Primary outcome
Occlusion time measurement
Time frame: at baseline
Measurement of the occlusion times of the 2 cartridges (collagen/ADP and collagen/epinephrine) with the classic 0.109M citrate tube and the BAPA tube, with any PLC alarms and observation of the stained blood smears.
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 29 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostasis, run by Centre Hospitalier Universitaire Dijon 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 3 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 29 Sep 2025. 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 Emmanuel De Maistre (03 80 29 32 57, 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?
Occlusion time measurement (time frame: at baseline). 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 29 Sep 2025.