Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05172778

Acronym

Enrollment

200

Registered

2021-12-29

Start date

2021-07-30

Completion date

2022-12-31

Last updated

2021-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Anticoagulant

Keywords

Lupus Anticoagulant, Coagulation, Phospholipid

Brief summary

Lupus anticoagulants (are antiphospholipid antibodies (PSA), the screening of which is done by demonstrating prolongation of coagulation times corrected by the intake of phospholipids (PL). Learned societies (ISTH, CLSI) thus recommend, for the research of LA, to carry out initially two screening tests with a low concentration in PL: a time of diluted Russell viper venom (DRVVT) as well as a time activated partial thromboplastin (TCA). If one of these screening tests is positive, it is recommended to perform a second confirmation test using the same principle (DRVVT or TCA) and containing a higher concentration of PL. The current LA screening method at the Hematology Laboratory of Strasbourg University Hospital includes: a pair of DRVVT screening / confirmation (STA-Staclot DRVV Screen and Confirm, Diagnostica Stago, France) and a screening TCA (PTT-A , Diagnostica Stago, France). This study aims to compare with the current method of the investigators a pair of TCA screening / confirmation (Cephen LS / Cephen, Hyphen Biomed, France).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Major subject * blood sample already analyzed in the laboratory as part of the treatment by the reference method * Patient who did not express his opposition to the reuse of his data and his blood sample for the technical study.

Exclusion criteria

* Minor patient * Patient under curatorship, guardianship or legal protection * Patient who expressed his opposition to the use of his data * Insufficient sample

Design outcomes

Primary

Measure	Time frame
Observational study of the performance of Cephen reagents in the context of research into lupus anticoagulants	Files analysed retrospectively from January 01, 2019 to December 31, 2021 will be examined]

Countries

France

Contacts

Primary ContactAgathe HERB, PharmD

agathe.herb@chru-strasbourg.fr33 3 88 12 75 53

Backup ContactSaïd CHAYER, PhD, HDR

said.chayer@chru-strasbourg.fr

Outcome results