OzENTER-TBI Core Study
The OzENTER-TBI (Australia-Europe NeuroTrauma Effectiveness Research in Traumatic Brain Injury) Study performed in Australia was conducted in 2 adult major trauma centres in Victoria at different intervals between February 2015 to March 2017. These centers receive 85% of adults with severe TBI from a state population of 6 million.
The E-CRF used was the same as for CENTER-TBI, both studies were longitudinal cohort studies with harmonized data points and outcome assessments, and the same inclusion criteria were valid, but for logistic reasons, not all variables from CENTER-TBI have been captured in OzENTER-TBI.
Therefor this dataset is more limited compared to CENTER-TBI: only ICU stratum; only CT (no MRI) scans in acute phase; no lab sampling performed; only waiver of consent, no confirmation of consent; no registration of other studies, other registries or associated trials; no physician concern recorded in TIL; only GOSE and SF-12 performed as outcome assessments (at 6/12 month only); no capture of follow up surgical data, follow up medications, follow up rehab data, follow up socio-economic data, …; GOSE was measured by either a postal questionnaire or a structured telephone interview by a trained assessor; Subject.GOSE6monthEndpointDerived does not include imputed values in the OzENTER data set. It equals the composite GOSE at 6 months.
A total of 198 ICU patients were included for OzENTER-TBI.
Visit OzENTER-TBI Core
Design
- Study design
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Other :
Study design and e-CRF for data collection were copied from the CENTER-TBI study to provide harmonized data points and outcome assessments, and allow for comparison between both studies.
For OzENTER patients of any age were included if they underwent a CT-scan of the brain and were admitted to the ICU within 24 hours of injury. Patients with a pre-existing neurological disorder that would otherwise confound outcome assessment were excluded.
- Follow Up
- Follow up assessments at 6 months and 12 months
Recruitment
- Sources of Recruitment
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- Other : ICU patients with TBI
Number of participants
- Number of participants
- 198
- Number of participants with biosamples
Access
Available on request
| Data | |
| Biosamples | |
| CT/MRI scans and HR ICU meta data |
Timeline
TBI patients OzENTER-TBI
Patients that underwent a CT-scan of the brain and were admitted to the ICU within 24 hours of injury.
Selection Criteria
- Countries
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- Australia
- Health Status
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- Other criteria
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Inclusion Criteria:
- Clinical diagnosis of TBI
- Clinical indication for CT scan
- Admission to ICU
Exclusion Criteria:
- Severe pre-existing neurological disorder that would confound outcome assessments
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- ICU patients with TBI
Number of participants
- Number of participants
- 198
- Number of participants with biosamples
Data Collection Event
- Start Date
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2015-02
- End Date
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2017-03
- Data sources
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- Acute care data
- Imaging
- Questionnaires