Tocilizumab: Tocilizumab 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: Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Modified Rankin Scale (mRS) score at 1 month after treatment — 1 month 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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