Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage (RHEOMICS)

University Hospital, Strasbourg, France

Status and phase: Not yet enrolling; Phase 4

Conditions: Hemorrhagic Disorders

Treatments: Biological: Prothrombin time

Study type: Interventional

Funder types: Other

Identifiers

NCT06974396

9696

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Isolated extrinsic pathway factor deficiency

Other group

Description:

Patients with an isolated extrinsic pathway factor deficiency (acquired or congenital) : II or V or VII or X

Treatment:

Biological: Prothrombin time

Hepatocellular insufficiency with coagulopathy

Other group

Description:

Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).

Treatment:

Biological: Prothrombin time