Traumatic Brain Injury Clinical Trial
Official title:
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.
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