RecruitingNCT06705829

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.


Sponsor

University Hospital, Strasbourg, France

Enrollment

100 participants

Start Date

Dec 14, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria2

  • 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).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALProthrombin

Comparison of prothrombin time results obtained with the different thromboplastins reagent for subgroup (extrinsic pathway factor and for those with hepatocellular insufficiency) by a regression line and a Bland-Altman representation. Comparison of extrinsic pathway factor assays obtained with the different thromboplastins reagent for each subgroup by a regression line and a Bland-Altman representation. Evaluation and determination of the sensitivity of the prothrombin time according to the activity rate obtained for each factor (for each reagent).


Locations(1)

Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie

Strasbourg, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06705829


Related Trials