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).
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.
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.
Parallel
Tocilizumab
DrugTocilizumab 240 mg will be diluted with 0.9% sodium chloride to a total volume of 100 mL and administered as a single intravenous infusion over more than 1 hour.
Standard Treatment
DrugParticipants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
Modified Rankin Scale (mRS) score at 1 month after treatment
The modified Rankin Scale (mRS) score will be assessed at 1 month after treatment. The mRS ranges from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate worse functional outcomes.
Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment
The modified Rankin Scale (mRS) score will be assessed at 2 weeks and 3 months after treatment. The mRS ranges from 0 to 6, with 0 indicating no symptoms and 6 indicating death. Higher scores indicate worse functional outcomes.
National Institutes of Health Stroke Scale (NIHSS) score at 2 weeks, 1 month, and 3 months after treatment
The National Institutes of Health Stroke Scale (NIHSS) score will be assessed at 2 weeks, 1 month, and 3 months after treatment. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment.
Headache Impact Test-6 (HIT-6) score at 2 weeks, 1 month, and 3 months after treatment
The Headache Impact Test-6 (HIT-6) score will be assessed at 2 weeks, 1 month, and 3 months after treatment. The HIT-6 total score ranges from 36 to 78, with higher scores indicating a greater impact of headache on daily functioning.
Intracranial pressure (ICP) at 2 weeks after treatment
Intracranial pressure (ICP) will be assessed at 2 weeks after treatment.
Incidence of recurrent cerebral venous thrombosis or other vascular events
The incidence of recurrent cerebral venous thrombosis or other vascular events will be assessed during follow-up. Other vascular events include venous thromboembolic events occurring during follow-up.
Incidence of serious adverse events related to anti-IL-6 treatment
Serious adverse events considered related to anti-IL-6 treatment will be recorded throughout the study period.
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