Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00112398




Registration number
NCT00112398
Ethics application status
Date submitted
2/06/2005
Date registered
3/06/2005
Date last updated
12/03/2013

Titles & IDs
Public title
Head Injury Retrieval Trial
Scientific title
Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
Secondary ID [1] 0 0
HIRT1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head Injuries, Closed 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Extended interventions by advanced level prehospital providers

Active Comparator: Standard (paramedic) prehospital care -

Experimental: Physician prehospital care -


Treatment: Surgery: Extended interventions by advanced level prehospital providers
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glasgow Outcome Scale Score
Timepoint [1] 0 0
Six months post injury
Secondary outcome [1] 0 0
Length of hospital and intensive care unit stays
Timepoint [1] 0 0
At hospital discharge
Secondary outcome [2] 0 0
30 day survival and survival to discharge from the acute care hospital
Timepoint [2] 0 0
At hospital discharge and 30 days
Secondary outcome [3] 0 0
Extended Glasgow Outcome Scale Score
Timepoint [3] 0 0
Six months post injury
Secondary outcome [4] 0 0
Disability Rating scale
Timepoint [4] 0 0
Six months post injury

Eligibility
Key inclusion criteria
- Glasgow Coma Scale score of 3 to 8 due to blunt trauma as measured at the accident
scene by the first prehospital team to arrive at the site.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Penetrating trauma

- Age less than 16 years

- No more than 5 casualties at the scene

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
338
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
CareFlight, PO Box 159 - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
CareFlight
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
NSW Motor Accident Authority
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study hypothesis is that advanced interventions as provided by a physician at an accident
scene will decrease the death rate and the rate of severe disability in survivors of severe
head injury. Extended interventions by advanced level prehospital providers may include rapid
sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00112398
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alan A Garner, FACEM
Address 0 0
CareFlight
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00112398