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.

Last updated: August 4, 2025
Sponsor: University Hospital, Strasbourg, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Red Blood Cell Disorders

Treatment

Prothrombin

Clinical Study ID

NCT06705829
IV-0196
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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).

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Prothrombin
Phase:
Study Start date:
December 14, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie

    Strasbourg, 67091
    France

    Active - Recruiting

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