Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163800
Status:
COMPLETED
Last Update Posted:
2005-12-08
First Post:
2005-09-12
Brief Title:
Outcome Predictors in Acute Brain Injury
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Outcome Predictors in Acute Brain Injury A Pilot Study
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None