Lupus AnticoagulantLANCT05172778
Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants
An observational study of Lupus Anticoagulant, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). 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
- 30 Jul 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 with blood sample already analyzed in the laboratory as part of the treatment by the reference method
Who may be able to join
- 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.
Who cannot join
- Minor patient
- Patient under curatorship, guardianship or legal protection
- Patient who expressed his opposition to the use of his data
- Insufficient sample
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Agathe HERB, PharmD, 33 3 88 12 75 53, agathe.herb@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
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.
Read more
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).
- Conditions
- Lupus Anticoagulant
- Keywords
- Lupus Anticoagulant, Coagulation, Phospholipid
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational study of the performance of Cephen reagents in the context of research into lupus anticoagulants
Measured: Files analysed retrospectively from January 01, 2019 to December 31, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start30 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completion31 Dec 2022 (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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agathe HERB, PharmD, Principal investigator, Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172778
- Sponsor's protocol ID
- 8246
- Acronym
- LA
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 29 Dec 2021
- 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 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Performance of Cephen Reagents in the Context of Research Into Lupus Anticoagulants
- ClinicalTrials.gov ID
- NCT05172778
- Acronym / sponsor ID
- LA / 8246
- Conditions
- Lupus Anticoagulant
- Keywords
- Lupus Anticoagulant, Coagulation, Phospholipid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Dec 2021 (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 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject with blood sample already analyzed in the laboratory as part of the treatment by the reference method
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Minor patient
- Patient under curatorship, guardianship or legal protection
- Patient who expressed his opposition to the use of his data
- Insufficient sample
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
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]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
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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. This study is not recruiting at the moment.
Saïd CHAYER, PhD, HDR contact
Agathe HERB, PharmD principal investigator
Laboratoire d'Hématologie - Hôpitaux Universitaires de Strasbourg
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Dec 2021. 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?
Results are not available in the source record.
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?
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]). 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 29 Dec 2021.