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LA: Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05172778
Collaborator
(none)
200
Enrollment
1
Location
17.1
Anticipated Duration (Months)
11.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lupus anticoagulants (are antiphospholipid antibodies (PSA), the screening of which is done by demonstrating prolongation of coagulation times corrected by the intake of phospholipids (PL).

Learned societies (ISTH, CLSI) thus recommend, for the research of LA, to carry out initially two screening tests with a low concentration in PL: a time of diluted Russell viper venom (DRVVT) as well as a time activated partial thromboplastin (TCA). If one of these screening tests is positive, it is recommended to perform a second confirmation test using the same principle (DRVVT or TCA) and containing a higher concentration of PL.

The current LA screening method at the Hematology Laboratory of Strasbourg University Hospital includes: a pair of DRVVT screening / confirmation (STA-Staclot DRVV Screen and Confirm, Diagnostica Stago, France) and a screening TCA (PTT-A , Diagnostica Stago, France).

This study aims to compare with the current method of the investigators a pair of TCA screening / confirmation (Cephen LS / Cephen, Hyphen Biomed, France).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants
    Actual Study Start Date :
    Jul 30, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Observational study of the performance of Cephen reagents in the context of research into lupus anticoagulants [Files analysed retrospectively from January 01, 2019 to December 31, 2021 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion criteria:

    • Major subject

    • blood sample already analyzed in the laboratory as part of the treatment by the reference method

    • Patient who did not express his opposition to the reuse of his data and his blood sample for the technical study.

    Exclusion criteria:

    • Minor patient

    • Patient under curatorship, guardianship or legal protection

    • Patient who expressed his opposition to the use of his data

    • Insufficient sample

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Agathe HERB, PharmD, Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05172778
    Other Study ID Numbers:
    • 8246
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    Dec 29, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Lupus Anticoagulant
    Coagulation
    Phospholipid

    Study Results

    No Results Posted as of Dec 29, 2021