Choice of Anticoagulant for Primary Hemostasis Studies With PFA200® (Platelet Function Analyser)

NCT06753838 | Recruiting

• 1 other identifier: DE MAISTRE 2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline

Study Arms (1)

Patients requiring a PFA test for the diagnosis of Willebrand disease

Biological: Sampling of 3 additional BAPA tubes

Interventions

Sampling of 3 additional BAPA tubes BIOLOGICAL

the 3 additional tubes will be taken at the same time as the blood sample taken for the routine PFA test

Patients requiring a PFA test for the diagnosis of Willebrand disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a PFA test

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Central Study Contacts

Emmanuel De Maistre

CONTACT

03 80 29 32 57; emmanuel.demaistre@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: January 21, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

FR (1)