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

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

• 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.