Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— GNOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212754
• Other study ID #: GNOS1
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: December 2019
• Source: University of Cambridge
• Contact: David Clark
• Phone: +441223336946
• Email: gnos[@]globalneurotrauma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 29, 2020
• Est. primary completion date: February 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Trauma
• Craniocerebral Trauma
• Emergencies
• Head Injury
• Head Injury Trauma
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.

Locations

Country	Name	City	State
United Kingdom	University of Cambridge	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality (or 14 day mortality, whichever comes first)		Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Secondary	Perioperative complications: Return to operating theatre	Including reason for return.	Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Secondary	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
Secondary	Length of stay in hospital (days)		Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Secondary	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
Secondary	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
Secondary	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.