Cryocheck HexLA integrated APTT test for detecting lupus anticoagulant
Official title: Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant
Run by University Hospital, Strasbourg, France · NCT07313475 · Data updated 2026-11-12
This work will test whether the Cryocheck HexLA integrated APTT better detects lupus anticoagulant and is less affected by anticoagulant medications in adults whose blood is sent to the HUS Hematology Laboratory.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | December 4, 2024 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07313475 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) whose blood samples are submitted to the HUS Hematology Laboratory for routine lupus anticoagulant testing are eligible.
✕Probably not a fit
People who do not have samples sent to the CHU de Strasbourg lab or whose samples lack sufficient volume are not included and will not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational laboratory comparison uses routine blood samples sent to the CHU de Strasbourg Hematology Laboratory for lupus anticoagulant (LA) testing. Samples will be tested with the Cryocheck HexLA integrated APTT and compared to the laboratory's current Cephen LS/Cephen integrated APTT workflow. The analysis will compare sensitivity for detecting LA and the degree to which results are distorted by concurrent anticoagulant therapy. No extra procedures are required beyond the routine diagnostic testing of submitted samples.
Why it matters
Potential benefit: If Cryocheck HexLA performs better, it could improve detection of lupus anticoagulant and reduce false results, especially in patients taking anticoagulant drugs.
How similar studies have gone: Previous reagent-comparison studies for LA testing have sometimes identified reagents with improved sensitivity, but Cryocheck HexLA itself is relatively new and less widely reported.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Laboratoire d'Hématologie - CHU de Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Agathe HERB, PharmD
- Email: agathe.herb@chru-strasbourg.fr
- Phone: 33 3 88 12 75 53
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.