Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury - a Multi-centre, International, Prospective Cohort Study (the Global Neurotrauma Outcomes Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- In-hospital mortality (or 14 day mortality, whichever comes first)
研究概览
简要总结
Primary aim:
The primary aim of the study is to compare survival to discharge (or survival to 14 days post-operatively, whichever comes first) following emergency surgery for traumatic brain injury (TBI) across Human Development Index settings.
Primary outcome measure:
The primary outcome measure will be survival to discharge (or survival to 14 days post-operatively, whichever comes first)
Primary comparison:
Between country groups defined by human development index.
Centre eligibility:
Any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate.
Patient eligibility:
All adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study.
Team:
Individual hospital teams with up to four people, collecting data for 30 days.
Time period:
Local study teams may select any 30-day period from the 1st of November 2018 and the 31st of December 2019 to start their study. Patients operated on who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included.
Validation:
We will employ a method of data validation in every centre that will give us a quantitative estimate of case ascertainment that is feasible even in low-resource centres.
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
- •Any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate. In the majority of institutions, emergency surgery for TBI is provided by neurosurgeons - however, centres in which emergency surgery for TBI is provided general surgeons, trauma surgeons, general medical doctors or even non-physician clinicians are also eligible to participate.
- •Inclusion Criteria:
- •All adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study.
排除标准
- •Patients who only have an external ventricular drain or intraparenchymal wire (or other monitoring device) inserted for the diagnosis and/or management of intracranial hypertension.
- •Patients who undergo procedures for chronic subdural haematoma(s), including burr holes or mini-craniotomies.
- •Elective (planned admission) or semi-elective (where patient initially admitted as an emergency, then discharged from hospital, and re-admitted at later time for surgery) procedures.
- •Patients who have previously had emergency cranial surgery for traumatic brain injury rendering them eligible for inclusion in this study (regardless of whether they were included)
结局指标
主要结局
In-hospital mortality (or 14 day mortality, whichever comes first)
时间窗: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
次要结局
- Length of stay in intensive care (days)(Up until hospital discharge, death or 14 days postoperatively, whichever comes first)
- Perioperative complications: Return to operating theatre(Up until hospital discharge, death or 14 days postoperatively, whichever comes first)
- Glasgow Coma Score at discharge/end of follow up period(At hospital discharge 14 days postoperatively, whichever comes first)
- Length of stay in hospital (days)(Up until hospital discharge, death or 14 days postoperatively, whichever comes first)
- Perioperative complications: Surgical site infection (SSI)(Up until hospital discharge, death or 14 days postoperatively, whichever comes first)
- Location that the patient was discharged to(Within 14 days post-operatively, only applies to patients who are discharged within this time period.)
研究者
David Clark
Clinical Research Fellow in Global Neurotrauma
University of Cambridge