Acute Brain InjuryNCT00163800
Outcome Predictors in Acute Brain Injury
An observational study of Acute Brain Injury, run by Bayside Health.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Brain Injury
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jul 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Glasgow Coma Scale < 9 post resuscitation
- Intubated and ventilated
- Traumatic brain injury
Who cannot join
- Pregnancy
About this study
Official title: Outcome Predictors in Acute Brain Injury, A Pilot Study
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.
Read the 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
- Acute Brain Injury
- Keywords
- Outcome predictors, Acute brain injury
- Medical subject headings
- Brain Injuries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Investigators
- Warwick Butt, FRACP, Principal investigator, Bayside Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163800
- Sponsor's protocol ID
- 189/02
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 8 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Predictors in Acute Brain Injury, A Pilot Study
- ClinicalTrials.gov ID
- NCT00163800
- Acronym / sponsor ID
- 189/02
- Conditions
- Acute Brain Injury
- Keywords
- Outcome predictors, Acute brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Bayside HealthOther government
- Study start
- Jul 2003
- Study completion
- Jul 2005
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Glasgow Coma Scale < 9 post resuscitation
- Intubated and ventilated
- Traumatic brain injury
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warwick Butt, FRACP principal investigator
Bayside Health
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injury, run by Bayside Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2005.