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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 :
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatocellular insufficiency with coagulopathy | Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prothrombin | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
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Inclusion criteria :
Exclusion criteria :
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Patient with an isolated (acquired or congenital) extrinsic pathway factor deficiency or with an hepatocellular insufficiency associated with a coagulopathy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Laurent WIMMER | Contact | +33 3 88127528 | jordan.wimmer@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie | Recruiting | Strasbourg | 67091 | France |
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Plasma samples obtained after centrifugation of whole blood samples collected in citrated tubes at 2500 g for 10 minutes.
|
| ID | Term |
|---|---|
| D006474 | Hemorrhagic Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011516 | Prothrombin |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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