Lupus AnticoagulantHEXLANCT07313475
Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant
An observational study of Lupus Anticoagulant, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Anticoagulant
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2024to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject blood sample already analyzed in the laboratory as part of the treatment by the reference method
Who may be able to join
- Patient of legal age (≥ 18 years)
- Sample sent to the HUS Hematology Laboratory and analyzed for LA detection as part of routine care.
Who cannot join
- Insufficient sample volume
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Laboratoire d'Hématologie - CHU de Strasbourg - France
Strasbourg, 67091
Agathe HERB, PharmD, 33 3 88 12 75 53, agathe.herb@chru-strasbourg.fr
Agathe HERB, PharmD
About this study
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
- Keywords
- Lupus Anticoagulant, Coagulation, Phospholipid, Time activated partial thromboplastin (TCA), Cryocheck HexLA, Cephen LS
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Cryocheck HexLA compared to Cephen LS/Cephen reagents with regard to lupus anticoagulant (LA)
A Fisher or McNemar statistical test on paired samples will be performed by comparing the results (positive or negative) of the integrated Cephen LS/Cephen and Cryocheck HexLA TCA tests, performed on the same sample, in patients not receiving anticoagulant therapy.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start4 Dec 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus AnticoagulantStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313475
- Sponsor's protocol ID
- 9486
- Acronym
- HEXLA
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cryocheck HexLA Integrated TCA for the Detection of Lupus Anticoagulant
- ClinicalTrials.gov ID
- NCT07313475
- Acronym / sponsor ID
- HEXLA / 9486
- Conditions
- Lupus Anticoagulant
- Keywords
- Lupus Anticoagulant, Coagulation, Phospholipid, Time activated partial thromboplastin (TCA), Cryocheck HexLA, Cephen LS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject blood sample already analyzed in the laboratory as part of the treatment by the reference method
Key inclusion criteria (2 listed)
- Patient of legal age (≥ 18 years)
- Sample sent to the HUS Hematology Laboratory and analyzed for LA detection as part of routine care.
Key exclusion criteria (1 listed)
- Insufficient sample volume
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Cryocheck HexLA compared to Cephen LS/Cephen reagents with regard to lupus anticoagulant (LA)
Time frame: Up to 9 months
A Fisher or McNemar statistical test on paired samples will be performed by comparing the results (positive or negative) of the integrated Cephen LS/Cephen and Cryocheck HexLA TCA tests, performed on the same sample, in patients not receiving anticoagulant therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Anticoagulant, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agathe HERB, PharmD (33 3 88 12 75 53, agathe.herb@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Cryocheck HexLA compared to Cephen LS/Cephen reagents with regard to lupus anticoagulant (LA) (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.