Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury (GNOS)

Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury - a Multi-centre, International, Prospective Cohort Study (the Global Neurotrauma Outcomes Study)

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.

Study Overview

• Status: Unknown
• Conditions: Brain Injuries; Brain Injuries, Traumatic; Traumatic Brain Injury; Head Injury; Brain Trauma; Head Injury Trauma
• Intervention / Treatment: Other: Exposure: human development index of country

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Recruiting
      • University of Cambridge
      • Contact: David Clark; Phone Number: +441223336946; Email: gnos@globalneurotrauma.com
      • Contact: Peter Hutchinson; Phone Number: +441223336946; Email: gnos@globalneurotrauma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients undergoing emergency surgery for traumatic brain injury.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Procedure: Emergency surgery for traumatic brain injury	Other: Exposure: human development index of country; Primary comparison: Between country groups defined by human development index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-hospital mortality (or 14 day mortality, whichever comes first)	Up until hospital discharge, death or 14 days postoperatively, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications: Return to operating theatre	Including reason for return.	Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Perioperative complications: Surgical site infection (SSI)	SSI is stratified into superficial and deep/organ space infection.	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)	For patients admitted to intensive care.	Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Glasgow Coma Score at discharge/end of follow up period	3-15, 3 signifies no eye opening, verbal response or motor response to painful stimulus, 15 signifies no impairment to consciousness. For patients surviving to discharge and/or 14 days postoperatively.	At hospital discharge 14 days postoperatively, whichever comes first
Location that the patient was discharged to	For patients surviving to discharge and discharged within 14 days post-operatively. Categorical variable for which the options are 'transfer to another hospital', 'transfer to rehabilitation unit', 'usual place of residence' and 'absconded'. A surrogate measure of short term functional outcome.	Within 14 days post-operatively, only applies to patients who are discharged within this time period.

Collaborators and Investigators

• Sponsor: University of Cambridge
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): February 13, 2020
• Study Completion (Anticipated): February 29, 2020

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Trauma, Nervous System; Emergencies; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: GNOS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of the main results, the pooled dataset will be available to all members of the GNOS collaboration for secondary analysis, after judgement and approval of each proposed analysis by the central study team.
• IPD Sharing Time Frame: After publication of the main results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No