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.

NCT06705829 | Recruiting

• 1 other identifier: IV-0196
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Disorders; Extrinsic Pathway Factor Deficiency; Hepatocellular Insufficiency With Coagulopathy

Keywords

Thromboplastin sensitivity; Prothrombin time

Outcome Measures

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.

  18 months

Study Arms (1)

Hepatocellular insufficiency with coagulopathy

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

Biological: Prothrombin

Interventions

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).

Hepatocellular insufficiency with coagulopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg - Laboratoire de Virologie

Strasbourg, 67091, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples obtained after centrifugation of whole blood samples collected in citrated tubes at 2500 g for 10 minutes.

MeSH Terms

Conditions

Hemorrhagic Disorders

Interventions

Prothrombin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Central Study Contacts

Jordan Laurent WIMMER

CONTACT

+33 3 88127528; jordan.wimmer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: December 14, 2024
• Primary Completion: December 14, 2024
• Study Completion: December 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (1)