Outcome Predictors in Acute Brain Injury
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|ClinicalTrials.gov Identifier: NCT00163800|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 8, 2005
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|
|Acute Brain Injury|
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 Type :||Observational|
|Enrollment :||60 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Outcome Predictors in Acute Brain Injury, A Pilot Study|
|Study Start Date :||July 2003|
|Study Completion Date :||July 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163800
|Principal Investigator:||Warwick Butt, FRACP||Bayside Health|