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

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 Overview

• Status: Recruiting
• Conditions: Hemostasis
• Intervention / Treatment: Biological: Sampling of 3 additional BAPA tubes

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Emmanuel De Maistre; Phone Number: 03 80 29 32 57; Email: emmanuel.demaistre@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourgogne
    • Contact: Emmanuel De Maistre; Phone Number: 03 80 29 32 57; Email: emmanuel.demaistre@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a PFA test

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients requiring a PFA test for the diagnosis of Willebrand disease	Biological: Sampling of 3 additional BAPA tubes; the 3 additional tubes will be taken at the same time as the blood sample taken for the routine PFA test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DE MAISTRE 2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No