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Clinical Trials/NCT00163800
NCT00163800
Completed
Not Applicable

Outcome Predictors in Acute Brain Injury, A Pilot Study

Bayside Health0 sites60 target enrollmentJuly 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Brain Injury
Sponsor
Bayside Health
Enrollment
60
Status
Completed
Last Updated
20 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2003
End Date
July 2005
Last Updated
20 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bayside Health

Eligibility Criteria

Inclusion Criteria

  • Glasgow Coma Scale \< 9 post resuscitation
  • Intubated and ventilated
  • Traumatic brain injury

Exclusion Criteria

  • Pregnancy

Outcomes

Primary Outcomes

Not specified

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