Cerebral Venous Thrombosis
Conditions
Keywords
Interleukin-6 Receptor Inhibitor, Cerebral venous thrombosis, Anticoagulation, Inflammation
Brief 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).
Detailed 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.
Interventions
DRUGTocilizumab
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.
DRUGStandard Treatment
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment | 2 weeks and 3 months | 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 | 2 weeks, 1 month, and 3 months | 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 | 2 weeks, 1 month, and 3 months. | 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 | 2 weeks | Intracranial pressure (ICP) will be assessed at 2 weeks after treatment. |
| Cerebral venous sinus recanalization status assessed by magnetic resonance venography (MRV) | 3 months | Cerebral venous sinus recanalization status will be evaluated using magnetic resonance venography (MRV) at 3 months after treatment. |
| Change in cerebral venous sinus stenosis and thrombus burden assessed by magnetic resonance black-blood thrombus imaging (MRBTI) | 3 months | Changes in cerebral venous sinus stenosis and thrombus burden will be evaluated using magnetic resonance black-blood thrombus imaging (MRBTI) at 3 months after treatment. |
Countries
China
Contacts
CONTACTXunming Ji
CONTACTChen Zhou
Outcome results
None listed