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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Cambridgeshire
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Cambridge, Cambridgeshire, Verenigd Koninkrijk, CB2 0QQ
- Werving
- University of Cambridge
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Contact:
- David Clark
- Telefoonnummer: +441223336946
- E-mail: gnos@globalneurotrauma.com
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Contact:
- Peter Hutchinson
- Telefoonnummer: +441223336946
- E-mail: gnos@globalneurotrauma.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Procedure: Emergency surgery for traumatic brain injury
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Primaire vergelijking: tussen landengroepen gedefinieerd door de index voor menselijke ontwikkeling.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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In-hospital mortality (or 14 day mortality, whichever comes first)
Tijdsspanne: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Perioperative complications: Return to operating theatre
Tijdsspanne: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Including reason for return.
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Perioperative complications: Surgical site infection (SSI)
Tijdsspanne: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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SSI is stratified into superficial and deep/organ space infection.
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Length of stay in hospital (days)
Tijdsspanne: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Length of stay in intensive care (days)
Tijdsspanne: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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For patients admitted to intensive care.
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Up until hospital discharge, death or 14 days postoperatively, whichever comes first
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Glasgow Coma Score at discharge/end of follow up period
Tijdsspanne: At hospital discharge 14 days postoperatively, whichever comes first
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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.
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At hospital discharge 14 days postoperatively, whichever comes first
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Location that the patient was discharged to
Tijdsspanne: Within 14 days post-operatively, only applies to patients who are discharged within this time period.
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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.
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Within 14 days post-operatively, only applies to patients who are discharged within this time period.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: David Clark, University of Cambridge
- Hoofdonderzoeker: Peter Hutchinson, University of Cambridge
- Hoofdonderzoeker: Alexis Joannides, University of Cambridge
- Hoofdonderzoeker: Angelos Kolias, University of Cambridge
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GNOS1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
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