Outcome Predictors in Acute Brain Injury

This study has been completed.
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163800
First received: September 12, 2005
Last updated: December 7, 2005
Last verified: September 2005
  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
Time Perspective: Longitudinal
Official Title: Outcome Predictors in Acute Brain Injury, A Pilot Study

Resource links provided by NLM:


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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163800

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

No publications provided

ClinicalTrials.gov Identifier: NCT00163800     History of Changes
Other Study ID Numbers: 189/02
Study First Received: September 12, 2005
Last Updated: December 7, 2005
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:
Outcome predictors
Acute brain injury

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

ClinicalTrials.gov processed this record on September 18, 2014