Clinical Trials Directory

Trials / Completed

CompletedNCT00163800

Outcome Predictors in Acute Brain Injury

Outcome Predictors in Acute Brain Injury, A Pilot Study

Status
Completed
Phase
Study type
Observational
Enrollment
60 (planned)
Sponsor
Bayside Health · Other Government
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2003-07-01
Completion
2005-07-01
First posted
2005-09-14
Last updated
2005-12-08

Source: ClinicalTrials.gov record NCT00163800. Inclusion in this directory is not an endorsement.