Cerebral Venous Thrombosis Cohort Study in China Mainland
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Death rate
研究概览
简要总结
This study was aimed to reveal the clinical features,natural history of the diseases and current therapeutic situations of cerebral venous thrombosis (CVT) in China mainland. Blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of CVT and identify the biomarkers for CVT.
详细描述
cerebral venous thrombosis (CVT) is caused by a clot in the cerebral vein, which resulted in an obstruction of the blood outflow. CVT mainly includes cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis. However, the epidemiological features of CVT in China mainland remained obscure. This study was aimed to establish a multicenter cohort recruiting patients with CVT across 31 provinces and municipalities in China mainland. Clinical features,natural history of the diseases and current therapeutic situations will be analyzed to reveal the epidemiological features of CVT. Blood samples and cerebrospinal fluid samples will be collected after recruitment to reveal the pathological mechanisms of CVT and identify the biomarkers for CVT. Patients will be followed-up at 1, 3, 6, 12 months from baseline to evaluate the clinical prognosis and therapeutic outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis diagnosed by digital subtraction angiography (DSA), magnetic resonance venography (MRV), computed tomography venography (CTV) or high-resolution magnetic resonance imaging (HR-MRI).
排除标准
- •None of the patient, trustee or immediate family members signed the informed consent.
结局指标
主要结局
Death rate
时间窗: 1 year from baseline
A combination of death form of all causes
Functional independence
时间窗: 1 year from baseline
Defined as modified Rankin score (0-5) equal to or lower than 2
Recurrence of cerebral venous sinus thrombosis, deep cerebral venous thrombosis and cortical vein thrombosis
时间窗: 1 year from baseline
Diagnosed by DSA, MRV, CTV or HR-MRI
Incidence of hemorrhagic complication
时间窗: 1 year from baseline
Extracranial hemorrhage (fall in hemoglobin of 2 gram/dl or more within 48 hours) or intracranial hemorrhage
Incidence of pulmonary embolism
时间窗: 1 year from baseline
Incidence of deep venous thrombosis
时间窗: 1 year from baseline
Incidence of sinus wall rupture
时间窗: 1 year from baseline
Incidence of acute ischemic stroke
时间窗: 1 year from baseline
Incidence of acute myocardial infarction
时间窗: 1 year from baseline
次要结局
- Incidence of epilepsy(1 year from baseline)
- Incidence of allergic reaction(1 year from baseline)
研究者
Ji Xunming,MD,PhD
Professor
Capital Medical University