Outcome Predictors in Acute Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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Acute Brain Injury

Keywords

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Outcome predictors Acute brain injury

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Warwick Butt, FRACP

Role: PRINCIPAL_INVESTIGATOR

Bayside Health

Other Identifiers

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189/02

Identifier Type: -

Identifier Source: org_study_id