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

NCT05172778 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-12-29

No results posted yet for this study

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).

Conditions

  • Lupus Anticoagulant

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Agathe HERB, PharmD · Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172778 on ClinicalTrials.gov