New Biological Tests in Patients With Antiphospholipid Antibodies
LYON SAPL
Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies
2 other identifiers
observational
150
1 country
4
Brief Summary
Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). APS diagnosis needs the presence of both clinical and serological criteria (SAPORRO criteria, updated with Sydney criteria in 2006). However, no correlation between laboratory assays and the clinical thrombosis risk in patients with aPL-Abs was observed as only few patients with aPL-Abs developed clinical manifestations. Thrombin generation assays (TGA) is a global coagulation test that may represent a certain interest to evaluate thrombosis risk as a high thrombin generation capacity seems to be an independent risk factor for recurrent thromboembolic events. Another point of interest to assess the thrombotic risk is the detection of autoantibodies recognizing domain 1 of β2Gp1 (aβ2GP1-dm1). These autoantibodies are strongly related correlated with thrombotic and pregnancy manifestations. Recently, a commercial chemiluminescence immunoassay (CLIA) for detection of aβ2GP1-dm1 became available on Acustar® analyzer (HemosIL Acustar®, Instrument Laboratory, Bedford, USA) to facilitate aβ2GP1-dm1 research. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2019
CompletedStudy Start
First participant enrolled
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 13, 2027
February 28, 2024
February 1, 2024
8 years
February 28, 2019
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
aβ2GP1-dm
The hypercoagulability status will be compared in each group. Each biological result of aβ2GP1-dm1 will be compared to a gold standard: 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.
One day
Endogenous Thrombin Potential (ETP)
The hypercoagulability status will be compared in each group. Each biological result of ETP will be compared to a gold standard: 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.
One day
peak of thrombin
The hypercoagulability status will be compared in each group. Each biological result of peak of thrombin will be compared to a gold standard: 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.
One day
lag time
The hypercoagulability status will be compared in each group. Each biological result of lag time will be compared to a gold standard: 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.
One day
time to peak
The hypercoagulability status will be compared in each group. Each biological result of time to peak will be compared to a gold standard: 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.
One day
Study Arms (3)
Biological APS
50 Asymptomatic patients with aPL antibodies and prolonged APTT
Obstetrical APS
50 patients with Obstetrical aPL syndrome
Thrombosis APS
APS with a personal history of venous or arterial thrombosis (50 patients)
Interventions
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
150 adult patients with known aPL-Abs (Antiphospholipid antibodies) will be including in the study after collecting their informed consent.
You may qualify if:
- Adult patients with confirmed aPL-Abs (at least two positive determinations at least 12 week apart)
- Subject non opposition
You may not qualify if:
- Age \< 18 years
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hôpital Cardiologique Louis Pradel
Bron, 69500, France
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
Hôpital Edouard Herriot
Lyon, 69421, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
Biospecimen
A single 15 mL blood draw is planned for this study, as follow: 10 mL citrated tube (2 tubes) for activated Partial Prothrombin Time (APTT), Prothrombin Time (PT), D-Dimers, Lupus anticoagulant (LA), Anti-cardiolipin antibodies (aCL), Anti-β2 Glycoprotein1 antibodies (aβ2GP1), Antibodies to Domain 1 (Dm1) of β2-Glycoprotein 1 (aβ2GP1-dm1) and Thrombin Generation Assay (TGA ) ; and 5 mL ethylenediaminetetraacetic acid (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. Platelet-poor plasmas will be prepared by double centrifugation at 2 500 g for 15 minutes at room temperature and then all citrated plasma samples will be stored at -80°C. At the end of the study, the remaining plasma samples (if any) will be destroyed.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2019
First Posted
March 26, 2019
Study Start
March 13, 2019
Primary Completion (Estimated)
March 13, 2027
Study Completion (Estimated)
March 13, 2027
Last Updated
February 28, 2024
Record last verified: 2024-02