NCT07313475

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Lupus Anticoagulant

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: France