How well different thromboplastin reagents work for prothrombin time in certain liver and factor deficiencies
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 · NCT06974396 · Data updated 2026-11-12
This study tests several thromboplastin reagents to see how they affect prothrombin time in patients with isolated extrinsic pathway deficiencies or liver-related coagulopathy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT06974396 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with isolated extrinsic pathway deficiencies (factors II, V, VII, or X) or hepatocellular insufficiency-related coagulopathy whose plasma samples can be analyzed after routine testing.
✕Probably not a fit
Patients receiving anticoagulants beyond specified exclusions or those without the target factor deficiencies or hepatic coagulopathy are unlikely to benefit from this testing approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares the performance of multiple thromboplastin reagents of various origins when measuring prothrombin time and specific factor II, V, VII, and X levels. It includes plasma samples from patients with isolated extrinsic pathway deficiencies or hepatocellular dysfunction and excludes those on anticoagulants. The goal is to determine reagent sensitivity and assay reliability to guide laboratories in selecting the most appropriate reagent for coagulopathy testing. Results may inform how PT reagents influence screening outcomes and factor assays across different etiologies of coagulopathy. The lead site is Strasbourg University Hospital, with no listed collaborators beyond the institution.
Why it matters
Potential benefit: If successful, the study could help laboratories choose the most suitable thromboplastin reagent for accurate PT testing and factor activity assessment in patients with extrinsic pathway deficiencies or liver-related coagulopathy.
How similar studies have gone: Previous work has shown that thromboplastin reagent origin can influence prothrombin time results in coagulopathy, supporting the potential value of this comparative approach.
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
-
Service de néphrologie
Strasbourg, France Recruiting
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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.