New Biological Tests in Patients With Antiphospholipid Antibodies

Recruiting

• Conditions: Antiphospholipid Syndrome
• Interventions: Biological: blood sample

• Registration Number: NCT03890601
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-28
• Study Start: 2019-03-13
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2027-03-13
• Study Completion: 2027-03-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult patients with confirmed aPL-Abs (at least two positive determinations at least 12 week apart)
• Subject non opposition

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biological APS	blood sample	50 Asymptomatic patients with aPL antibodies and prolonged APTT
Obstetrical APS	blood sample	50 patients with Obstetrical aPL syndrome
Thrombosis APS	blood sample	APS with a personal history of venous or arterial thrombosis (50 patients)

Primary Outcome Measures

Name	Time	Method
aβ2GP1-dm	One day	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.
Endogenous Thrombin Potential (ETP)	One day	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.
peak of thrombin	One day	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.
lag time	One day	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.
time to peak	One day	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.

Trial Locations

Locations (4)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital Cardiologique Louis Pradel; 🇫🇷 Bron, France