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Functional and Mechanistic Analysis of Antiphospholipid Antibody-Induced Inhibition of Thrombin Generation

Functional and Mechanistic Analysis of Antiphospholipid Antibody-Induced Inhibition of Thrombin Generation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129596
Enrollment
Unknown
Registered
2026-08-06
Start date
2026-08-06
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antiphospholipid syndrome (APS)

Interventions

Observation group:None

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Informed consent: Voluntarily sign the written informed consent form. 2.Age: 18 to 75 years (inclusive), either gender. 3.APS diagnosis: Diagnosed with APS according to the 2006 Sydney International APS Classification Criteria or the 2023 ACR/EULAR APS Classification Criteria.

Exclusion criteria

Exclusion criteria: 1. Concurrent other definite inherited or acquired bleeding disorders (e.g., hemophilia, von Willebrand disease, acquired factor VIII deficiency, etc.); 2. Concurrent severe liver disease (Child-Pugh Class C) or severe renal insufficiency (eGFR < 30 mL/min/1.73 m^2); 3. Currently using other medications that may significantly affect coagulation function besides anticoagulant/antiplatelet drugs (e.g., certain antibiotics, antifungals); 4. Concurrent active infection, malignancy, or psychiatric disorder that precludes cooperation with the study; 5. Pregnant or breastfeeding women; 6. Anemia (hemoglobin < 90 g/L) judged by the investigator as unsuitable for a 20 mL blood draw.

Design outcomes

Primary

MeasureTime frame
Inhibition rate (%) of thrombin generation (ETP, peak thrombin) in normal plasma by patient-purified IgG/IgM;

Countries

China

Contacts

Public ContactHui Shi

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

shihui_sjtu@sina.com+86 21 6437 0045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026