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

Study acronym: RHEOMICS
StatusRecruiting
PhasePhase 4
Started2025-12-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
notable
Study Status, Contacts/Locations v2
Recruitment opened
Start dateestimated 2025-09-01→confirmed 2025-12-01
2025-08-01
minor
Study Status v1
Re-verified, no change to tracked fields
2025-05-14
minor
Original filing
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.
Trial Details
NCT Number NCT06974396
Lead Sponsor University Hospital, Strasbourg, France
Conditions Hemorrhagic Disorders
Enrollment 20 participants
Start Date 2025-12-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-19