Traumatic Brain InjuryGNOSNCT04212754
Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Head Injury, run by University of Cambridge at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatic Brain Injury, Head Injury, Brain Injuries
- What is being tested?
- Exposure: human development index of country
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 29 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients undergoing emergency surgery for traumatic brain injury.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Cambridge
Cambridge, Cambridgeshire, CB2 0QQ
David Clark, +441223336946, gnos@globalneurotrauma.com
Peter Hutchinson, +441223336946, gnos@globalneurotrauma.com
About this study
Official title: 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.
Read more
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
- Being tested
- Exposure: human development index of country
- Medical subject headings
- Brain Injuries, Traumatic, Craniocerebral Trauma, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: human development index of countryOther
Primary comparison: Between country groups defined by human development index.
| Study group | Role | What they receive |
|---|---|---|
| Procedure: Emergency surgery for traumatic brain injury | Not described Receives: Other: Exposure: human development index of country |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality (or 14 day mortality, whichever comes first)
Measured: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Secondary outcomes (6)
Perioperative complications: Return to operating theatre
Including reason for return.
Measured: 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.
Measured: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Length of stay in hospital (days)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 14 days post-operatively, only applies to patients who are discharged within this time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Nov 2018
- Primary completion13 Feb 2020 (estimated)
- Study completion29 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Clark, University of Cambridge
- Investigators
- David Clark, Principal investigator, University of CambridgePeter Hutchinson, Principal investigator, University of CambridgeAlexis Joannides, Principal investigator, University of CambridgeAngelos Kolias, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212754
- Sponsor's protocol ID
- GNOS1
- Acronym
- GNOS
- Status last verified
- Dec 2019
- First submitted
- 23 Dec 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Menon AA, Clark D, Bath MF, Venturini S, Bashir M, Joannides A, Adeleye AO, Bajamal AH, Biluts H, Budohoski K, Ercole A, Fernandez-Mendez R, Figaji A, Gupta D, Hartl R, Iaccarino C, Khan T, Laeke T, Rubiano AM, Shabani HK, Sichizya K, Tewari M, Tirsit A, Thu M, Tripathi M, Trivedi R, Devi BI, Servadei F, Menon D, Kolias A, Bashford T, Hutchinson P; Global Neurotrauma Outcomes Study collaborative. Outlining the global variation in resources for traumatic brain injury care: site-level data from the Global Neurotrauma Outcomes Study (GNOS). BMJ Glob Health. 2026 Apr 28;11(4):e023154. doi: 10.1136/bmjgh-2025-023154.
PubMed 42049390
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury - a Multi-centre, International, Prospective Cohort Study (the Global Neurotrauma Outcomes Study)
- ClinicalTrials.gov ID
- NCT04212754
- Acronym / sponsor ID
- GNOS / GNOS1
- Conditions
- Traumatic Brain Injury, Head Injury, Brain Injuries, Brain Trauma, Brain Injuries, Traumatic, Head Injury Trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 13 Feb 2020 (estimated)
- Study completion
- 29 Feb 2020 (estimated)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Procedure: Emergency surgery for traumatic brain injury | – | Other: Exposure: human development index of country |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients undergoing emergency surgery for traumatic brain injury.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: human development index of countryPrimary comparison: Between country groups defined by human development index. | Other | Procedure: Emergency surgery for traumatic brain injury |
Primary outcome
In-hospital mortality (or 14 day mortality, whichever comes first)
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
6 secondary outcomes
Perioperative complications: Return to operating theatre
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Perioperative complications: Surgical site infection (SSI)
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Length of stay in hospital (days)
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Length of stay in intensive care (days)
Time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
Glasgow Coma Score at discharge/end of follow up period
Time frame: At hospital discharge 14 days postoperatively, whichever comes first
Location that the patient was discharged to
Time frame: Within 14 days post-operatively, only applies to patients who are discharged within this time period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Derived from this study: PubMed 42049390Menon AA, Clark D, Bath MF, Venturini S, Bashir M, Joannides A, Adeleye AO, Bajamal AH, Biluts H, Budohoski K, Ercole A, Fernandez-Mendez R, Figaji A, Gupta D, Hartl R, Iaccarino C, Khan T, Laeke T, Rubiano AM, Shabani HK, Sichizya K, Tewari M, Tirsit A, Thu M, Tripathi M, Trivedi R, Devi BI, Servadei F, Menon D, Kolias A, Bashford T, Hutchinson P; Global Neurotrauma Outcomes Study collaborative. Outlining the global variation in resources for traumatic brain injury care: site-level data from the Global Neurotrauma Outcomes Study (GNOS). BMJ Glob Health. 2026 Apr 28;11(4):e023154. doi: 10.1136/bmjgh-2025-023154.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Clark principal investigator
University of Cambridge
Peter Hutchinson principal investigator
University of Cambridge
Alexis Joannides principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Head Injury, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Clark (+441223336946, gnos@globalneurotrauma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (or 14 day mortality, whichever comes first) (time frame: Up until hospital discharge, death or 14 days postoperatively, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04212754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.