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.
Recruiting now
Conditions studied: Hemorrhagic Disorders, Extrinsic Pathway Factor Deficiency, Hepatocellular Insufficiency With Coagulopathy
In brief
Primary purpose : Compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients : * Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X. * Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment). Results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.
Key facts
- Study ID
- NCT06705829
- Run by
- University Hospital, Strasbourg, France
- People needed
- 100
- Starts
- 2024-12-14
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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 is running
- Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie — Strasbourg, France (enrolling)
Full record on ClinicalTrials.gov
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