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Outcome Predictors in Acute Brain Injury

Sponsor
Bayside Health (Other)
Overall Status
Completed
CT.gov ID
NCT00163800
Collaborator
(none)
60
Enrollment
24
Duration (Months)

Study Details

Study Description

Brief Summary

This study will attempt to evaluate clinical, laboratory and radiographic parameters together to assess heir values in outcome prediction from brain injury. Patients will be followed up for a period of 6 months, following admission to ICU, to assess outcome, using the Extended Glasgow Outcome Score (GOSE).

We hypothesise that it is possible to reliably predict outcome in brain injury from the current investigations we have at our disposal.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Design- A prospective clinical trial of patients admitted to intensive care with acute brain injury due to trauma.

    Setting- Intensive Care Unit of the Alfred Hospital Clinical Examination- Day 4 and day 8, ICU consultant to assess prognosis and score patient.

    Electrophysiology- Day 4 and day 8, SSEP and EEG. Interpretation by person blinded to the patient.

    CT Brain- Day 1, day 4 and day 8. Interpretation by radiologist blinded to the patient.

    Blinding- Persons blinded to the patients will make all interpretations of investigations. Mode of brain injury will be made available.

    Follow up of patients- Structured interviews by telephone will be performed at 6 months post injury with the patient alone, relatives/ friend/ carer alone or patient and relatives/ friend/ carer. These will be performed in relation to the Extended Glasgow Outcome Scale (GOSE).

    Statistics- The positive and negative predictive values for the tests will be determined.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Prospective
    Official Title:
    Outcome Predictors in Acute Brain Injury, A Pilot Study
    Study Start Date :
    Jul 1, 2003
    Study Completion Date :
    Jul 1, 2005

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      16 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Glasgow Coma Scale < 9 post resuscitation

      • Intubated and ventilated

      • Traumatic brain injury

      Exclusion Criteria:
      • Pregnancy

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Bayside Health

      Investigators

      • Principal Investigator: Warwick Butt, FRACP, Bayside Health

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00163800
      Other Study ID Numbers:
      • 189/02
      First Posted:
      Sep 14, 2005
      Last Update Posted:
      Dec 8, 2005
      Last Verified:
      Sep 1, 2005
      Keywords provided by , ,
      Outcome predictors
      Acute brain injury
      Additional relevant MeSH terms:
      Brain Injuries
      Wounds and Injuries

      Study Results

      No Results Posted as of Dec 8, 2005