Multi-center Prospective Investigation of Incidence and Risk Factors of Peri-operative Stroke in Non-cardiac,Non-neurosurgical Surgeries and Practicability of NIHSS in Screening Peri-operative Strokes
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 6
- 主要终点
- perioperative stroke occurs during and within 30 days after surgery.
研究概览
简要总结
Stroke is an important cause of perioperative morbidity and mortality, particularly in patients > 60 years. In cardiac, neurological and carotid surgery the incidence is known to be high (2.2-5.2%). However, little is known regarding perioperative stroke following other types of surgery including general, urological, orthopedic, thoracic and gynecological procedures. We therefore propose to undertake a multicenter, observational cohort study, to determine the current incidence of, the risk factors for, and outcome associated with perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.
详细描述
Patient population: Prospective cohort study of 10,000 adults undergoing non-cardiac, non-neurological surgery.
Screening and enrollment: Consecutive patients undergoing (elective or emergency) non-cardiac, non-neurosurgical surgeries will be recruited.
Monitoring, follow-up, and data collection: Usual treatment will be provided. Demographic details will be recorded. Patients will be visited regularly in hospital. Patient will be reviewed for neurologic deficit using the mNIHSS. Brain imaging will be performed to confirm stroke event. Follow-up at 30 days after discharge will be done to ascertain if there is any adverse outcome.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages Eligible for Study: 60 Years and older
- •Genders Eligible for Study: Both
- •Accepts Healthy Volunteers: No
- •Sampling Method: Probability Sample
排除标准
- •hospital stay after surgery less than 3 days
- •not consent of the assessment
- •surgery canceled
结局指标
主要结局
perioperative stroke occurs during and within 30 days after surgery.
时间窗: 30 days after suegery
The primary outcome is perioperative stroke occurs during and within 30 days after surgery. This is defined as cerebral infarction or hemorrhage on computer tomography or magnetic resonance scan, or new neurological signs (paralysis, weakness or speech difficulties) lasting more than 24 hours or leading to death. The mechanism of stroke will be classified using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.
次要结局
- total mortality and other major vascular complications up until 30 days after surgery(30 days after suegery)