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RECRUITING
NCT07313475

Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant

Sponsor: University Hospital, Strasbourg, France

View on ClinicalTrials.gov

Summary

Lupus anticoagulant (LA) testing is performed using two screening tests: activated partial thromboplastin time (APTT) and diluted Russell's viper venom time. If one of the screening tests is positive, a confirmation test based on the same principle is performed. The HUS Hematology Laboratory uses an integrated APTT for LA testing, consisting of a screening reagent: Cephen LS, and a confirmation reagent: Cephen (Hyphen Biomed). The aim of this study is to determine whether another integrated activated partial thromboplastin time (APTT) test, Cryocheck HexLA, offers better performance than Cephen LS/Cephen, both in terms of sensitivity to lupus anticoagulant (LA) and susceptibility to interference from anticoagulant treatments.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2024-12-04

Completion Date

2026-02

Last Updated

2026-01-02

Healthy Volunteers

Not specified

Locations (1)

Laboratoire d'Hématologie - CHU de Strasbourg - France

Strasbourg, France