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NCT Number: NCT06705829

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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Jordan Laurent WIMMER

CONTACT

[email protected]

+33 388127528

Jordan Laurent WIMMER

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prothrombin

Biological

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).

Primary outcomes

  1. Comparison of the sensitivity of several thromboplastin reagents on prothrombin time and factor II, V, VII and X assays

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Laurent WIMMER

CONTACT

[email protected]

+33 3 88127528

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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