Trials / Unknown
UnknownNCT04212754
Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury
Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury - a Multi-centre, International, Prospective Cohort Study (the Global Neurotrauma Outcomes Study)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- University of Cambridge · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Traumatic Brain Injury
- Head Injury
- Brain Injuries
- Brain Trauma
- Brain Injuries, Traumatic
- Head Injury Trauma
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Exposure: human development index of country | Primary comparison: Between country groups defined by human development index. |
Timeline
- Start date
- 2018-11-01
- Primary completion
- 2020-02-13
- Completion
- 2020-02-29
- First posted
- 2019-12-30
- Last updated
- 2019-12-30
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04212754. Inclusion in this directory is not an endorsement.