An observational study in Traumatic Brain Injury, Head Injury and Brain Injuries, sponsored by University of Cambridge. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2019-12-30.
Sponsored by University of Cambridge · Observational
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.
1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →University of Cambridge is the lead sponsor of 115 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients undergoing emergency surgery for traumatic brain injury.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Other: Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.
In-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.
Plan to share: Yes — After publication of the main results, the pooled dataset will be available to all members of the GNOS collaboration for secondary analysis, after judgement and approval of each proposed analysis by the central study team.
Supporting information: Study protocol
Time frame: After publication of the main results.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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