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| Sponsored by: |
Bayside Health |
|---|---|
| Information provided by: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00163800 |
Purpose
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 |
|---|
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Acute Brain Injury |
| Study Type: | Observational |
| Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
| Official Title: | Outcome Predictors in Acute Brain Injury, A Pilot Study |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | July 2005 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 189/02 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 7, 2005 |
| ClinicalTrials.gov Identifier: | NCT00163800 History of Changes |
| Health Authority: | Australia: National Health and Medical Research Council |
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Outcome predictors Acute brain injury |
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Craniocerebral Trauma Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Brain Injuries |
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Craniocerebral Trauma Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Brain Diseases Brain Injuries |
