Cryocheck HexLA integrated APTT test for detecting lupus anticoagulant
Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07313475 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) whose blood samples are submitted to the HUS Hematology Laboratory for routine lupus anticoagulant testing are eligible.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Strasbourg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.