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

NCT06974396 | Not Yet Recruiting Phase 4

• 1 other identifier: 9696
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Comparison of the sensitivity of several thromboplastin reagents of different origins (animal, human synthetic recombinant and human placental extraction) on prothrombin time and factor II, V, VII and X assays.

  Plasma samples were frozen at -80°C within 3 hours of collection and were serially analyzed few weeks later by thawing at 37°C within 2 hours after thawing.

Study Arms (2)

Isolated extrinsic pathway factor deficiency

OTHER

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

Biological: Prothrombin time

Hepatocellular insufficiency with coagulopathy

OTHER

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

Biological: Prothrombin time

Interventions

Prothrombin time 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; Isolated extrinsic pathway factor deficiency

Eligibility Criteria

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

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

MeSH Terms

Conditions

Hemorrhagic Disorders

Interventions

Prothrombin Time

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share