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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial population

Patient with an isolated (acquired or congenital) extrinsic pathway factor deficiency or with an hepatocellular insufficiency associated with a coagulopathy.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Prothrombin

    Biological/Vaccine

    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).

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Hepatocellular insufficiency with coagulopathy1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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