Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- favorable functional outcome.
研究概览
简要总结
The cohort study aims to evaluate the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis.
详细描述
Background: Evidence suggests that the inflammatory response plays a crucial role in regulating severe CVT pathogenesis. However, whether CVT patients can benefit from anti-inflammatory therapy has been debated.
Objective
The objective of this cohort study is to explore the efficacy and safety of steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe cerebral venous thrombosis (CVT) patients.
Method: We reviewed the data of patients with acute/subacute severe CVT treated with a short-term application of steroid or not from a prospective stroke registry of our center. We compared functional outcomes and major adverse events at 6 months follow-up after discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute or subacute severe CVT, determined by the onset-to-admission time (≤ 15 days) or symptom aggravation-to-admission time (≤ 15 days) and MRI+MRV/MRBTI (MR Black-Blood Thrombus Imaging), or CT+CTV
排除标准
- •younger than 14 years；
- •foreign nationality；
- •receiving steroids before the onset of CVT；
- •patients with other serious diseases；
- •Presenting with neurological deficits before the onset of CVT；
- •lack of baseline data before treatment；
- •receiving steroids during hospitalization for other reasons but the dosage did not reach pulsed-therapy level
- •brain herniation but refusing to undergo decompressive craniectomy, or pupillary light reflex did not recover after decompressive craniectomy
研究组 & 干预措施
Steroid therapy group
Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy.
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
favorable functional outcome.
时间窗: 6 months after discharge
mRS score ≤2 indicates favorable functional outcome.
次要结局
- Serious steroid complications during hospitalization(from admission to discharge (up to 4 weeks after admission))
- Serious steroids complications within 6 months after discharge(6 months after discharge)
研究者
JiangangDuan
MD, PhD
Xuanwu Hospital, Beijing