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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Subject non opposition

Locations
Other Locations
France
Hôpital Cardiologique Louis Pradel
RECRUITING
Bron
CHU de Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Hôpital Edouard Herriot
RECRUITING
Lyon
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Contact Information
Primary
Yesim DARGAUD, PH
gamze.dargaud@chu-lyon.fr
4.72.11.88.10
Backup
Stéphanie Désage
stephanie.desage@chu-lyon.fr
Time Frame
Start Date: 2019-03-13
Estimated Completion Date: 2027-03-13
Participants
Target number of participants: 150
Treatments
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)
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov