Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury

NCT04212754 | Unknown

• 1 other identifier: GNOS1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Head Injury; Brain Injuries; Brain Trauma; Brain Injuries, Traumatic; Head Injury Trauma

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality (or 14 day mortality, whichever comes first)

  Up until hospital discharge, death or 14 days postoperatively, whichever comes first

Secondary Outcomes (6)

• Perioperative complications: Return to operating theatre

  Up until hospital discharge, death or 14 days postoperatively, whichever comes first

• Perioperative complications: Surgical site infection (SSI)

  Up until hospital discharge, death or 14 days postoperatively, whichever comes first

• Length of stay in hospital (days)

  Up until hospital discharge, death or 14 days postoperatively, whichever comes first

• Length of stay in intensive care (days)

  Up until hospital discharge, death or 14 days postoperatively, whichever comes first

• Glasgow Coma Score at discharge/end of follow up period

  At hospital discharge 14 days postoperatively, whichever comes first

Study Arms (1)

Procedure: Emergency surgery for traumatic brain injury

Other: Exposure: human development index of country

Interventions

Exposure: human development index of country OTHER

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

Procedure: Emergency surgery for traumatic brain injury

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing emergency surgery for traumatic brain injury.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

University of Cambridge

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Clark

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• Peter Hutchinson

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• Alexis Joannides

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• Angelos Kolias

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Clark

CONTACT

+441223336946; gnos@globalneurotrauma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow in Global Neurotrauma

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 30, 2019
• Study Start: November 1, 2018
• Primary Completion: February 13, 2020
• Study Completion: February 29, 2020
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of the main results.

Locations

GB (1)