Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000382370
Ethics application status
Approved
Date submitted
9/03/2017
Date registered
14/03/2017
Date last updated
8/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of head injury prognostic calculators
Scientific title
Comparative study of two tools in determining severe head injury outcomes in an Australian setting: CRASH (Corticosteroid Randomisation after Significant Head injury) versus IMPACT (International Mission for Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury)
Secondary ID [1] 291406 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe traumatic brain injury (TBI) 302423 0
Condition category
Condition code
Neurological 301990 301990 0 0
Other neurological disorders
Injuries and Accidents 302031 302031 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
CRASH (Corticosteroid Randomisation After Significant Head Injury)
-This prognostic model may be used as an aid to estimate mortality at 14 days and death and severe disability at six months in patients with traumatic brain injury (TBI). The predictions are based on the average outcome in adult patients with Glasgow coma score (GCS) of 14 or less, within 8 hours of injury, and can support clinical judgment.

-Duration of observation of each participant is 6 months (from admission to 6 months post admission)
Intervention code [1] 297438 0
Diagnosis / Prognosis
Comparator / control treatment
IMPACT (International Mission for Prognosis and Analysis of Clinical Trials in TBI)
-Based on extensive prognostic analysis, this prognostic model was developed for predicting 6 month outcomes in adult patients with moderate to severe head injury (Glasgow Coma Scale <=12) on admission. By entering patient admission details into the calculator, the models will provide an estimate of the expected outcome at 6 months.
-There are three models of increasing complexity (Core, Core + CT, Core + CT + Lab). These were developed and validated in collaboration with the CRASH trial collaborators on large numbers of individual patient data (the IMPACT database).
Control group
Active

Outcomes
Primary outcome [1] 301413 0
CRASH outcome: Risk of unfavourable outcome at 6 months (%)
-Assessed by plugging patient admission and CT data (e.g. age, Glasgow Coma Scale score on admission, presence of traumatic subarachnoid haemorrhage on CT) into calculator and pressing 'Calculate'
Timepoint [1] 301413 0
6 months post admission
Primary outcome [2] 301414 0
IMPACT outcome: Core and Core + CT and Core + CT + Lab predicted probability of 6 month unfavourable outcome (%)
-All are assessed by plugging patient admission, CT and lab data (e.g. age, Glasgow Coma Scale score on admission, petechial hemorrhages on CT and blood glucose levels on admission) into calculator and pressing 'Calculate'
Timepoint [2] 301414 0
6 months post admission
Secondary outcome [1] 332563 0
Glasgow Outcome Scale (GOS)
Timepoint [1] 332563 0
6 months post admission

Eligibility
Key inclusion criteria
The inclusion criteria consists of participants with severe head injury requiring intubation (i.e. Glasgow Coma Scale <8).
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria consists of previously physically or mentally disabled participants (in order to maintain uniformity in outcome).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
-Statistical analysis of data shall assess discrimination using a 95% confidence interval, as well as the AUC (area under the curve).
-Adequate model discriminatory ability is represented by AUC greater or equal to 0.8, and model non-discriminatory ability is represented by AUC less than or equal to 0.5.
-The H-L goodness-of-fit test shall be used to assess calibration. It uses predicted probabilities to divide participants into deciles, followed by a computation of a x-squared from expected as well as observed frequencies.
-The x-squared distribution enables calculation of a p-value. A p-value of <0.05 is considered as significant.
-The Cox calibration analysis derives the slope and intercept from a logistical regression model. The degree of predictions variation is represented by the slope, being a coefficient of the predicted probability's logit. The slope equals 1 for an ideal model.
-The intercept, on the other hand, measures overall calibration by indicating systematically if predictions are too high or too low, and is zero in an ideal model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2017
Actual
1/01/2011
Date of last participant enrolment
Anticipated
Actual
31/12/2016
Date of last data collection
Anticipated
Actual
31/12/2017
Sample size
Target
200
Accrual to date
Final
256
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7646 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 15557 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 295879 0
Hospital
Name [1] 295879 0
Princess Alexandra Hospital
Country [1] 295879 0
Australia
Primary sponsor type
Individual
Name
Dr Ananthababu Pattavilakom Sadasivan
Address
Dept of Neurosurgery, Princess Alexandra Hospital,
199 Ipswich Rd,
WOOLLOONGABBA,
QLD 4102
Country
Australia
Secondary sponsor category [1] 294740 0
None
Name [1] 294740 0
N/A
Address [1] 294740 0
N/A
Country [1] 294740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297158 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 297158 0
Ethics committee country [1] 297158 0
Australia
Date submitted for ethics approval [1] 297158 0
Approval date [1] 297158 0
19/09/2016
Ethics approval number [1] 297158 0
HREC/16/QPAH/462- SSA/16/QPAH/463

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73174 0
Miss Harini Ravi
Address 73174 0
Dept of Neurosurgery, Princess Alexandra Hospital,
199 Ipswich Rd,
WOOLLOONGABBA,
QLD 4102
Country 73174 0
Australia
Phone 73174 0
+61411824152
Fax 73174 0
Email 73174 0
[email protected]
Contact person for public queries
Name 73175 0
Ananthababu Pattavilakom Sadasivan
Address 73175 0
Dept of Neurosurgery, Princess Alexandra Hospital,
199 Ipswich Rd,
WOOLLOONGABBA,
QLD 4102
Country 73175 0
Australia
Phone 73175 0
+61411824152
Fax 73175 0
Email 73175 0
[email protected]
Contact person for scientific queries
Name 73176 0
Ananthababu Pattavilakom Sadasivan
Address 73176 0
Department of Neurosurgery, Princess Alexandra Hospital,
199 Ipswich Rd,
WOOLLOONGABBA,
QLD 4102
Country 73176 0
Australia
Phone 73176 0
+61411536689
Fax 73176 0
Email 73176 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.