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

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.

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Key information

Conditions

Lupus Anticoagulant Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratoire d'Hématologie - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Agathe HERB, PharmD

CONTACT

[email protected]

33 3 88 12 75 53

Agathe HERB, PharmD

PRINCIPAL_INVESTIGATOR

Tomas MISEVICIUS, PharmD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Agathe HERB, PharmD

CONTACT

[email protected]

33 3 88 12 75 53

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: HEXLA

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jan 2, 2026
Registry last updated: Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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