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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Primary comparison: Between country groups defined by human development index.
University of Cambridge
Cambridge, Cambridgeshire, United Kingdom
RECRUITINGIn-hospital mortality (or 14 day mortality, whichever comes first)
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Perioperative complications: Return to operating theatre
Including reason for return.
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Perioperative complications: Surgical site infection (SSI)
SSI is stratified into superficial and deep/organ space infection.
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Length of stay in hospital (days)
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Length of stay in intensive care (days)
For patients admitted to intensive care.
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Glasgow Coma Score at discharge/end of follow up period
3-15, 3 signifies no eye opening, verbal response or motor response to painful stimulus, 15 signifies no impairment to consciousness. For patients surviving to discharge and/or 14 days postoperatively.
Time frame: At hospital discharge 14 days postoperatively, whichever comes first
Location that the patient was discharged to
For patients surviving to discharge and discharged within 14 days post-operatively. Categorical variable for which the options are 'transfer to another hospital', 'transfer to rehabilitation unit', 'usual place of residence' and 'absconded'. A surrogate measure of short term functional outcome.
Time frame: Within 14 days post-operatively, only applies to patients who are discharged within this time period.
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