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Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury

NCT04212754 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-12-30

No results posted yet for this study

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

Interventions

OTHER

Exposure: human development index of country

Primary comparison: Between country groups defined by human development index.

Sponsors & Collaborators

Principal Investigators

  • David Clark · University of Cambridge

  • Peter Hutchinson · University of Cambridge

  • Alexis Joannides · University of Cambridge

  • Angelos Kolias · University of Cambridge

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-02-13
Completion
2020-02-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04212754 on ClinicalTrials.gov