Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie
Strasbourg, 67091, France
Location status: Recruiting
Location contact
Jordan Laurent WIMMER
CONTACT
Jordan Laurent WIMMER
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06705829
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Strasbourg, 67091, France
Location status: Recruiting
Jordan Laurent WIMMER
CONTACT
Jordan Laurent WIMMER
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Strasbourg, France
Other
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