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Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury (GNOS)

24. december 2019 opdateret af: David Clark, University of Cambridge

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Consecutive patients undergoing emergency surgery for traumatic brain injury.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Procedure: Emergency surgery for traumatic brain injury
Andet: Eksponering: menneskelig udviklingsindeks for landet
Primær sammenligning: Mellem landegrupper defineret ved menneskelig udviklingsindeks.

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Cambridge

Efterforskere

  • Ledende efterforsker: David Clark, University of Cambridge
  • Ledende efterforsker: Peter Hutchinson, University of Cambridge
  • Ledende efterforsker: Alexis Joannides, University of Cambridge
  • Ledende efterforsker: Angelos Kolias, University of Cambridge

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2018

Primær færdiggørelse (Forventet)

13. februar 2020

Studieafslutning (Forventet)

29. februar 2020

Datoer for studieregistrering

Først indsendt

23. december 2019

Først indsendt, der opfyldte QC-kriterier

24. december 2019

Først opslået (Faktiske)

30. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GNOS1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

After publication of the main results.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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