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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: David Clark
- Número de teléfono: +441223336946
- Correo electrónico: gnos@globalneurotrauma.com
Ubicaciones de estudio
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Cambridgeshire
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Cambridge, Cambridgeshire, Reino Unido, CB2 0QQ
- Reclutamiento
- University of Cambridge
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Contacto:
- David Clark
- Número de teléfono: +441223336946
- Correo electrónico: gnos@globalneurotrauma.com
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Contacto:
- Peter Hutchinson
- Número de teléfono: +441223336946
- Correo electrónico: gnos@globalneurotrauma.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Procedure: Emergency surgery for traumatic brain injury
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Comparación primaria: Entre grupos de países definidos por el índice de desarrollo humano.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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In-hospital mortality (or 14 day mortality, whichever comes first)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perioperative complications: Return to operating theatre
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David Clark, University of Cambridge
- Investigador principal: Peter Hutchinson, University of Cambridge
- Investigador principal: Alexis Joannides, University of Cambridge
- Investigador principal: Angelos Kolias, University of Cambridge
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GNOS1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Lesiones Cerebrales
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