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New Biological Tests in Patients With Antiphospholipid Antibodies (LYON SAPL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890601
Recruitment Status : Unknown
Verified April 2019 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : March 26, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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.


Condition or disease Intervention/treatment
Antiphospholipid Syndrome Biological: blood sample

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : March 13, 2021
Estimated Study Completion Date : March 13, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Biological APS
50 Asymptomatic patients with aPL antibodies and prolonged APTT
 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, 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
 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, 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)
 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, 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.


Outcome Measures
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Primary Outcome Measures :
  1. aβ2GP1-dm [ Time Frame: 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.

  2. Endogenous Thrombin Potential (ETP) [ Time Frame: 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.

  3. peak of thrombin [ Time Frame: 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.

  4. lag time [ Time Frame: 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.

  5. time to peak [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
150 adult patients with known aPL-Abs (Antiphospholipid antibodies) will be including in the study after collecting their informed consent.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890601


Contacts
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Contact: Yesim DARGAUD, PH 4.72.11.88.10 ext +33 gamze.dargaud@chu-lyon.fr
Contact: Stéphanie Désage stephanie.desage@chu-lyon.fr

Locations
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France
Hôpital Cardiologique Louis Pradel Recruiting
Bron, France, 69500
Contact: Yesim DARGAUD, PH    04.72.11.88.10 ext +33    gamze.dargaud@chu-lyon.fr   
Contact: Stéphanie Désage       stephanie.desage@chu-lyon.fr   
Principal Investigator: Yesim DARGAUD, PH         
CHU de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Aurélien LEBRETON, MD, PhD    0473750200 ext +33    alebreton@chu-clermontferrand.fr   
Principal Investigator: Aurélien LEBRETON, MD, PhD         
Hôpital Edouard Herriot Recruiting
Lyon, France, 69421
Contact: Arnaud HOT, PH    0472117565 ext +33    arnaud.hot@chu-lyon.fr   
Contact: Hélène DESMURS CLAVEL, MD, PhD    0472117565 ext +33    helene.desmurs-clavel@chu-lyon.fr   
Principal Investigator: Arnaud HOT, PH         
Sub-Investigator: Hélène DESMURS CLAVEL, MD, PhD         
Centre Hospitalier Lyon Sud Recruiting
Pierre-Bénite, France, 69310
Contact: Claire GRANGE, MD,PhD    0478861463 ext +33    claire.grange@chu-lyon.fr   
Principal Investigator: Claire GRANGE, MD,PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03890601    
Other Study ID Numbers: 69HCL18_0522
2018-A03020-55 ( Other Identifier: ID-RCB )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Autoimmune Diseases
Immune System Diseases