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临床试验/NCT05448248
NCT05448248已完成不适用

A Registry Study of Cerebral Venous Sinus Thrombosis in China

Capital Medical University1 个研究点 分布在 1 个国家目标入组 3,276 人开始时间: 2022年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,276
试验地点
1
主要终点
Favorable clinical outcome (modified Rankin score 0-1)

研究概览

简要总结

This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.

详细描述

The epidemiology, risk factors, diagnosis and treatment of Cerebral Venous Thrombosis (CVT) in China are still unclear. A retrospective hospital-based study will be conducted at fifty different hospitals across 31 provinces in China. This study will use ICD-10 to search patients diagnosed with CVT between January 1, 2018 and June 15, 2022 across 31 provinces and municipalities of 104 hospitals in China. Risk factors, clinical and radiological findings, treatment and short-term outcomes will be recorded from the hospital record system. Finally, a prospective follow-up will be conducted for all of the patients enrolled above. By combining data collected from retrospective hospital records with the new follow-up, it will be possible to better understand the epidemiology, risk factors, diagnosis, treatment and the long-term prognosis of CVT in China.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

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

Favorable clinical outcome (modified Rankin score 0-1)

时间窗: Baseline to three years

All-cause mortality

时间窗: Baseline to three years

A combination of death form of all causes

次要结局

  • Recanalization rate of cerebral venous system(Baseline to three years)
  • Incidence of epilepsy(Baseline to three years)
  • Incidence of pulmonary embolism(Baseline to three years)
  • Recurrence of cerebral venous thrombosis(Baseline to three years)
  • Headache after CVT(Baseline to three years)
  • Incidence of acute ischemic stroke(Baseline to three years)
  • Favorable clinical outcome (modified Rankin score 0-2)(Baseline to three years)
  • Incidence of hemorrhagic complication(Baseline to three years)
  • Psychological distress after CVT(Baseline to three years)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji Xunming,MD,PhD

Capital Medical University

Capital Medical University

研究点 (1)

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