Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage
NCT ID: NCT06974396
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2025-09-01
2026-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Isolated extrinsic pathway factor deficiency
Patients with an isolated extrinsic pathway factor deficiency (acquired or congenital) : II or V or VII or X
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).
Hepatocellular insufficiency with coagulopathy
Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X).
Exclusion Criteria
* Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Other Identifiers
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9696
Identifier Type: -
Identifier Source: org_study_id
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