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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, Storbritannia, CB2 0QQ
- Rekruttering
- University of Cambridge
-
Ta kontakt med:
- David Clark
- Telefonnummer: +441223336946
- E-post: gnos@globalneurotrauma.com
-
Ta kontakt med:
- Peter Hutchinson
- Telefonnummer: +441223336946
- E-post: gnos@globalneurotrauma.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Procedure: Emergency surgery for traumatic brain injury
|
Primær sammenligning: Mellom landgrupper definert av menneskelig utviklingsindeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
In-hospital mortality (or 14 day mortality, whichever comes first)
Tidsramme: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Perioperative complications: Return to operating theatre
Tidsramme: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
Including reason for return.
|
Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
|
Perioperative complications: Surgical site infection (SSI)
Tidsramme: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
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)
Tidsramme: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
|
|
Length of stay in intensive care (days)
Tidsramme: Up until hospital discharge, death or 14 days postoperatively, whichever comes first
|
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
Tidsramme: At hospital discharge 14 days postoperatively, whichever comes first
|
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
Tidsramme: Within 14 days post-operatively, only applies to patients who are discharged within this time period.
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: David Clark, University of Cambridge
- Hovedetterforsker: Peter Hutchinson, University of Cambridge
- Hovedetterforsker: Alexis Joannides, University of Cambridge
- Hovedetterforsker: Angelos Kolias, University of Cambridge
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GNOS1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .