Comparing thromboplastin reagents for prothrombin time and clotting factor tests
Official title: Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage.
Run by University Hospital, Strasbourg, France · NCT06705829 · Data updated 2026-11-12
This project tests whether different thromboplastin reagents change prothrombin time and factor II, V, VII, and X results in people with isolated extrinsic pathway deficiencies or liver-related coagulopathy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | December 14, 2024 |
| Main results expected | December 14, 2024 |
| Study ends | December 2025 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT06705829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients whose plasma shows isolated or combined deficiencies of extrinsic pathway factors (II, V, VII, X) or patients with hepatocellular insufficiency and associated coagulopathy, and who are not taking excluded anticoagulant therapies.
✕Probably not a fit
Patients actively treated with oral anticoagulants or most parenteral anticoagulants are excluded and would not benefit from this comparison, nor would people without extrinsic pathway or liver-related coagulation problems.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will test multiple commercial thromboplastin reagents on anonymized plasma samples from two patient groups: those with isolated extrinsic pathway factor deficiencies (II, V, VII, X) and those with hepatocellular insufficiency-associated coagulopathy. They will measure prothrombin time and perform factor II, V, VII, and X assays across reagents to compare sensitivity and analytical performance. Samples from patients on oral or most parenteral anticoagulants will be excluded to avoid confounding effects. The goal is to identify which reagents give the most reliable screening and factor assay results to guide reagent selection for hemostasis laboratories.
Why it matters
Potential benefit: If successful, the work could help laboratories choose reagents that produce more reliable clotting test results, improving diagnosis and treatment decisions for patients with bleeding disorders or liver-related coagulopathy.
How similar studies have gone: Previous laboratory comparisons have shown variability in thromboplastin reagent sensitivity, so this work builds on existing findings though direct comparisons across these specific patient groups are relatively limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria : * Plasma samples from patients addressed to the laboratory of the Strasbourg University Hospital (Strasbourg France) collected and anonymized after completion of the routine testing. * Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X). Exclusion criteria : * Patient treated with an oral anticoagulant treatment. * Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).
Where it's running
-
Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Jordan Laurent WIMMER
- Email: jordan.wimmer@chru-strasbourg.fr
- Phone: +33 3 88127528
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.