Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis

Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis

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).

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.

Inclusion Criteria:

1. Aged 18-80 years.
2. Acute cerebral venous thrombosis (CVT) confirmed by neuroimaging, including MRI, MRV, CTV, MRBTI, or DSA.
3. Time from symptom onset to enrollment within 14 ± 14 days.
4. Written informed consent obtained from the participant.
5. Ability and willingness to comply with the study protocol and scheduled follow-up visits.

Exclusion Criteria:

1. Treatment with immunosuppressive agents within 7 days before enrollment.
2. Isolated cortical vein thrombosis or isolated cavernous sinus thrombosis.
3. Concomitant immune-related diseases, including Behçet disease or systemic lupus erythematosus.
4. Concomitant infectious diseases.
5. Primary or secondary immunodeficiency.
6. Concomitant hematologic disorders or inherited coagulation abnormalities.
7. Intracerebral hemorrhage with extension into the ventricular system or subarachnoid space.
8. Imaging evidence of midline shift >10 mm or cerebral herniation. Moderate or severe hepatic impairment, defined as Child-Pugh class B or C.
9. Creatinine clearance <30 mL/min.
10. Severe trauma or major surgery within 2 weeks before enrollment.
11. Serious comorbid disease that may result in an unfavorable prognosis within 1 year.
12. Pregnancy, puerperium, or breastfeeding.
13. Contraindication to anti-IL-6 therapy.
14. Contraindication to anticoagulant therapy.
15. Psychiatric illness or inability to cooperate with study-related examinations or treatment.
16. Known allergy to contrast agents or study medication.