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Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage

NCT06974396 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-06

No results posted yet for this 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.

Conditions

  • Hemorrhagic Disorders

Interventions

BIOLOGICAL

Prothrombin time

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).

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-12-01
Completion
2026-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06974396 on ClinicalTrials.gov