Overview
This study aims to evaluate the efficacy and safety of tocilizumab, an interleukin-6 (IL-6) receptor antagonist, combined with standard anticoagulant therapy compared with standard anticoagulant therapy alone in patients with acute cerebral venous thrombosis (CVT).
Description
Background: Inflammation, particularly IL-6-mediated inflammatory responses, may contribute to disease progression and brain injury in acute cerebral venous thrombosis (CVT).
Objective: This study aims to evaluate the efficacy and safety of tocilizumab combined with standard anticoagulant therapy in patients with acute CVT.
Method: This is a prospective, randomized, double-blind, placebo-controlled trial. Eligible patients with acute CVT are randomly assigned to receive standard anticoagulant therapy plus a single intravenous dose of tocilizumab or placebo. Clinical outcomes, laboratory parameters, imaging findings, and adverse events are assessed during hospitalization and follow-up.
Eligibility
Inclusion Criteria:
- Aged 18-80 years.
- Acute cerebral venous thrombosis (CVT) confirmed by neuroimaging, including MRI, MRV, CTV, MRBTI, or DSA.
- Time from symptom onset to enrollment within 14 ± 14 days.
- Written informed consent obtained from the participant.
- Ability and willingness to comply with the study protocol and scheduled follow-up visits.
Exclusion Criteria:
- Treatment with immunosuppressive agents within 7 days before enrollment.
- Isolated cortical vein thrombosis or isolated cavernous sinus thrombosis.
- Concomitant immune-related diseases, including Behçet disease or systemic lupus erythematosus.
- Concomitant infectious diseases.
- Primary or secondary immunodeficiency.
- Concomitant hematologic disorders or inherited coagulation abnormalities.
- Intracerebral hemorrhage with extension into the ventricular system or subarachnoid space.
- Imaging evidence of midline shift \>10 mm or cerebral herniation. Moderate or severe hepatic impairment, defined as Child-Pugh class B or C.
- Creatinine clearance \<30 mL/min.
- Severe trauma or major surgery within 2 weeks before enrollment.
- Serious comorbid disease that may result in an unfavorable prognosis within 1 year.
- Pregnancy, puerperium, or breastfeeding.
- Contraindication to anti-IL-6 therapy.
- Contraindication to anticoagulant therapy.
- Psychiatric illness or inability to cooperate with study-related examinations or treatment.
- Known allergy to contrast agents or study medication.
