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Outcome Predictors in Acute Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163800
First Posted: September 14, 2005
Last Update Posted: December 8, 2005
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.
Information provided by:
Bayside Health
  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
Acute Brain Injury

Study Type: Observational
Study Design: 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

Further study details as provided by Bayside Health:

Estimated Enrollment: 60
Study Start Date: July 2003
Estimated Study Completion Date: July 2005
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.

  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00163800


Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Warwick Butt, FRACP Bayside Health
  More Information

ClinicalTrials.gov Identifier: NCT00163800     History of Changes
Other Study ID Numbers: 189/02
First Submitted: September 12, 2005
First Posted: September 14, 2005
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