Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lupus Anticoagulant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Sensitivity of Cryocheck HexLA compared to Cephen LS/Cephen reagents with regard to lupus anticoagulant (LA) [Time frame: Up to 9 months]
Eligibility criteria
Inclusion criteria
- Patient of legal age (≥ 18 years)
- Sample sent to the HUS Hematology Laboratory and analyzed for LA detection as part of routine care.
Exclusion criteria
\- Insufficient sample volume
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Laboratoire d'Hématologie - CHU de Strasbourg - France — Strasbourg
Identifiers
NCT: NCT07313475 · 9486