Brain Injuries, Brain Injuries, Traumatic, Brain Trauma, Head Injury, Head Injury Trauma, Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
Primary comparison: Between country groups defined by human development index.
Sponsors
University of Cambridge
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-hospital mortality (or 14 day mortality, whichever comes first) | Up until hospital discharge, death or 14 days postoperatively, whichever comes first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative complications: Surgical site infection (SSI) | Up until hospital discharge, death or 14 days postoperatively, whichever comes first | SSI is stratified into superficial and deep/organ space infection. |
| Length of stay in hospital (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 | Including reason for return. |
| Glasgow Coma Score at discharge/end of follow up period | At hospital discharge 14 days postoperatively, whichever comes first | 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. |
| Location that the patient was discharged to | Within 14 days post-operatively, only applies to patients who are discharged within this time period. | 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. |
| Length of stay in intensive care (days) | Up until hospital discharge, death or 14 days postoperatively, whichever comes first | For patients admitted to intensive care. |
Countries
United Kingdom
Contacts
Primary ContactDavid Clark
Outcome results
None listed