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Completed

NCT Number: NCT00163800

Outcome Predictors in Acute Brain Injury

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy

Sponsors and collaborators

Lead sponsor

Bayside Health

Other Gov

Registry information

Official study title

Outcome Predictors in Acute Brain Injury, A Pilot Study

Important dates

Study start
2003
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Dec 8, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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