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

December 10, 2021 updated by: University Hospital, Strasbourg, France

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Agathe HERB, ParmD
        • Sub-Investigator:
          • Adrien Thiriet, ParmD
        • Sub-Investigator:
          • Anne-Sophie Korganow, MD, PhD
        • Sub-Investigator:
          • Thierry Martin, MD, PhD
        • Sub-Investigator:
          • Vincent Poindron, MD
        • Sub-Investigator:
          • Aurore Meyer, MD
        • Sub-Investigator:
          • Aurélien Guffroy, MD
        • Sub-Investigator:
          • Mathilde Herber, MD
        • Sub-Investigator:
          • Jeanne Tardif d'Hamonville, MD
        • Sub-Investigator:
          • Léa JACQUEL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Major subject with blood sample already analyzed in the laboratory as part of the treatment by the reference method

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Agathe HERB, PharmD, Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8246

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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