Extrinsic Pathway Factor Deficiency, Hemorrhagic Disorders, Hepatocellular Insufficiency With Coagulopathy
Conditions
Keywords
Thromboplastin sensitivity, Prothrombin time
Brief 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.
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).
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the sensitivity of several thromboplastin reagents on prothrombin time and factor II, V, VII and X assays | 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. |
Countries
France
Contacts
Primary ContactJordan Laurent WIMMER
Outcome results
None listed