NCT06705829 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.
| NCT ID | NCT06705829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Hemorrhagic Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-14 |
| Primary Completion | 2024-12-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-12-14 with a primary completion date of 2024-12-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06705829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemorrhagic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06705829 currently recruiting?
Yes, NCT06705829 is actively recruiting participants. Contact the research team at jordan.wimmer@chru-strasbourg.fr for enrollment information.
Where is the NCT06705829 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT06705829 clinical trial?
NCT06705829 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 100 participants.