New Biological Tests in Patients With Antiphospholipid Antibodies

Antiphospholipid Syndrome Clinical Trial

— LYON SAPL  

Official title:

Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03890601
• Other study ID #: 69HCL18_0522
• Secondary ID: 2018-A03020-55
• Status: Recruiting
• Start date: March 13, 2019
• Est. completion date: March 13, 2027

Study information

• Verified date: February 2024
• Source: Hospices Civils de Lyon
• Contact: Yesim DARGAUD, PH
• Phone: 4.72.11.88.10
• Email: gamze.dargaud[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 13, 2027
• Est. primary completion date: March 13, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome

Intervention

Biological:
• 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, aß2GP1, aß2GP1-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 aß2GP1-dm1.

Locations

Country	Name	City	State
France	Hôpital Cardiologique Louis Pradel	Bron
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	Hôpital Edouard Herriot	Lyon
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aß2GP1-dm	The hypercoagulability status will be compared in each group. Each biological result of aß2GP1-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
Primary	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
Primary	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
Primary	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
Primary	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