Anticoagulation Combined With Tocilizumab for Interleukin-6 Receptor Inhibition in Acute Cerebral Venous Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1-month modified Rankin Scale (mRS) score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard treatment
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of placebo.
干预措施: Standard Treatment (Drug)
Tocilizumab
Participants will receive guideline-recommended standard treatment plus a single intravenous infusion of tocilizumab.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
1-month modified Rankin Scale (mRS) score
时间窗: 1 month
The primary endpoint is the modified Rankin Scale (mRS) score at 1 month after treatment.
Modified Rankin Scale (mRS) score at 1 month after treatment
时间窗: 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.
次要结局
- The primary endpoint is the modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment.(2 weeks and 3 months)
- National Institutes of Health Stroke Scale (NIHSS) scores assessed at 2 weeks, 1 month, and 3 months after treatment.(2 weeks, 1 month, and 3 months)
- Headache Impact Test-6 (HIT-6) scores assessed at 2 weeks, 1 month, and 3 months after treatment.(2 weeks, 1 month, and 3 months.)
- intracranial pressure (ICP) assessed 2 weeks after treatment(2 weeks)
- Cerebral venous sinus recanalization assessed by MRV(3 months)
- Improvement in cerebral venous sinus stenosis or thrombus burden assessed by MRBTI(3 months)
- Modified Rankin Scale (mRS) score at 2 weeks and 3 months after treatment(2 weeks and 3 months)
- 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)
- Headache Impact Test-6 (HIT-6) score at 2 weeks, 1 month, and 3 months after treatment(2 weeks, 1 month, and 3 months.)
- Intracranial pressure (ICP) at 2 weeks after treatment(2 weeks)
- Cerebral venous sinus recanalization status assessed by magnetic resonance venography (MRV)(3 months)
- Change in cerebral venous sinus stenosis and thrombus burden assessed by magnetic resonance black-blood thrombus imaging (MRBTI)(3 months)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University