Outcome Predictors in Acute Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163800
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 8, 2005
Information provided by:
Bayside Health

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.

Condition or disease
Acute Brain Injury

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.

Study Type : Observational
Enrollment : 60 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Outcome Predictors in Acute Brain Injury, A Pilot Study
Study Start Date : July 2003
Study Completion Date : July 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00163800

Sponsors and Collaborators
Bayside Health
Principal Investigator: Warwick Butt, FRACP Bayside Health Identifier: NCT00163800     History of Changes
Other Study ID Numbers: 189/02
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 8, 2005
Last Verified: September 2005

Keywords provided by Bayside Health:
Outcome predictors
Acute brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System