New Biological Tests in Patients With Antiphospholipid Antibodies
NCT ID: NCT03890601
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2019-03-13
2027-03-13
Brief Summary
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The aim of this study is to evaluate two additional laboratory assays to improve the correlation between laboratory assays and the clinical thrombosis risk in patients with antiphospholipid (APL): thrombin generation assay and aβ2GP1-dm1. Each biological result (Antibodies to Domain 1 (Dm1) of β2-Glycoprotein 1 (aβ2GP1-dm1) and Thrombin Generation Test (TGT) parameters: endogen thrombin potential (ETP), lag time and time to peak) will be compared to the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Biological APS
50 Asymptomatic patients with aPL antibodies and prolonged APTT
blood sample
A single 15 mL blood draw is planned for this study, as follow:
* 10 mL citrated tube (2 tubes) for APTT, PT, D-Dimers, LA, aCL, aβ2GP1, aβ2GP1-dm1 and TGA
* 5 mL EDTA tube for blood count
During a follow up visit, a 5 ml citrated tube and a 5 mL EDTA tube are collected from each patient for their routine laboratory evaluation. One additional citrated tube will be required to measure thrombin generation and aβ2GP1-dm1.
Obstetrical APS
50 patients with Obstetrical aPL syndrome
blood sample
A single 15 mL blood draw is planned for this study, as follow:
* 10 mL citrated tube (2 tubes) for APTT, PT, D-Dimers, LA, aCL, aβ2GP1, aβ2GP1-dm1 and TGA
* 5 mL EDTA tube for blood count
During a follow up visit, a 5 ml citrated tube and a 5 mL EDTA tube are collected from each patient for their routine laboratory evaluation. One additional citrated tube will be required to measure thrombin generation and aβ2GP1-dm1.
Thrombosis APS
APS with a personal history of venous or arterial thrombosis (50 patients)
blood sample
A single 15 mL blood draw is planned for this study, as follow:
* 10 mL citrated tube (2 tubes) for APTT, PT, D-Dimers, LA, aCL, aβ2GP1, aβ2GP1-dm1 and TGA
* 5 mL EDTA tube for blood count
During a follow up visit, a 5 ml citrated tube and a 5 mL EDTA tube are collected from each patient for their routine laboratory evaluation. One additional citrated tube will be required to measure thrombin generation and aβ2GP1-dm1.
Interventions
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blood sample
A single 15 mL blood draw is planned for this study, as follow:
* 10 mL citrated tube (2 tubes) for APTT, PT, D-Dimers, LA, aCL, aβ2GP1, aβ2GP1-dm1 and TGA
* 5 mL EDTA tube for blood count
During a follow up visit, a 5 ml citrated tube and a 5 mL EDTA tube are collected from each patient for their routine laboratory evaluation. One additional citrated tube will be required to measure thrombin generation and aβ2GP1-dm1.
Eligibility Criteria
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Inclusion Criteria
* Subject non opposition
Exclusion Criteria
* Patient under the protection of justice, under guardianship or under curatorship
* Patient with anticoagulant treatment, except heparin
* Clinically symptomatic liver disease, supported by e.g. diagnosis of cirrhosis, portal hypertension, ascites, PT superior or egal to 5 seconds above upper normal limit
* Platelet count \< 100 G/L (giga/liter)
* Poor venous access
* Non confirmed suspicion of APS
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hôpital Cardiologique Louis Pradel
Bron, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Edouard Herriot
Lyon, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A03020-55
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL18_0522
Identifier Type: -
Identifier Source: org_study_id
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