Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury

Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury - a Multi-centre, International, Prospective Cohort Study (the Global Neurotrauma Outcomes Study)

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.

Centre Inclusion Criteria:

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.

Exclusion Criteria:

• 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)