Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury
NCT ID: NCT04212754
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2018-11-01
2020-02-29
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Procedure: Emergency surgery for traumatic brain injury
Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.
Interventions
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Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.
Eligibility Criteria
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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 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)
ALL
No
Sponsors
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University of Cambridge
OTHER
Responsible Party
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David Clark
Clinical Research Fellow in Global Neurotrauma
Principal Investigators
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David Clark
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Peter Hutchinson
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Alexis Joannides
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Angelos Kolias
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Locations
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University of Cambridge
Cambridge, Cambridgeshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David Clark
Role: primary
Peter Hutchinson
Role: backup
Other Identifiers
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GNOS1
Identifier Type: -
Identifier Source: org_study_id