Clinical trial NCT04212754: Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury
Official title: Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury - a Multi-centre, International, Prospective Cohort Study (the Global Neurotrauma Outcomes Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Head Injury
Brain Injuries
Brain Trauma
Brain Injuries, Traumatic
Head Injury Trauma
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing emergency surgery for traumatic brain injury.

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.


Eligibility 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)

Primary outcomes:
measure: In-hospital mortality (or 14 day mortality, whichever comes first)
timeFrame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Secondary outcomes:
measure: Perioperative complications: Return to operating theatre
timeFrame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
measure: Perioperative complications: Surgical site infection (SSI)
timeFrame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
measure: Length of stay in hospital (days)
timeFrame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
measure: Length of stay in intensive care (days)
timeFrame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
measure: Glasgow Coma Score at discharge/end of follow up period
timeFrame: At hospital discharge 14 days postoperatively, whichever comes first
measure: Location that the patient was discharged to
timeFrame: Within 14 days post-operatively, only applies to patients who are discharged within this time period.
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: David Clark
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cambridge
name: Peter Hutchinson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cambridge
name: Alexis Joannides
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cambridge
name: Angelos Kolias
role: PRINCIPAL_INVESTIGATOR
References: