Evaluating new biological tests for patients with antiphospholipid antibodies
Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies
This study is testing new blood tests to see if they can help predict the risk of blood clots in people with antiphospholipid syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Bron and 3 other locations) |
| Trial ID | NCT03890601 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with antiphospholipid syndrome (APS), an autoimmune condition linked to thromboembolic events and pregnancy complications. It aims to explore the relationship between laboratory tests, specifically thrombin generation assays and autoantibodies recognizing domain 1 of β2Gp1, and the clinical risk of thrombosis in patients with antiphospholipid antibodies. By analyzing blood samples from participants, the study seeks to identify potential biomarkers that could better predict thrombotic risks in these patients. The findings may enhance the understanding of APS and improve patient management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with confirmed antiphospholipid antibodies.
Not a fit: Patients under 18 years old or those with certain exclusions, such as anticoagulant treatment or non-confirmed suspicion of APS, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with antiphospholipid syndrome.
How similar studies have performed: While the approach of using thrombin generation assays is promising, it is still being explored, and similar studies have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bron and 3 other locations
- Hôpital Cardiologique Louis Pradel — Bron, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- Hôpital Edouard Herriot — Lyon, France (Recruiting)
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Study coordinator: Yesim DARGAUD, PH
- Email: gamze.dargaud@chu-lyon.fr
- Phone: 4.72.11.88.10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.