Head Injury Retrieval Trial
March 10, 2013 updated by: Alan Garner, CareFlight
Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
A randomised, controlled trial examining prehospital management of persons with severe blunt head injury, in the Sydney region.
Treatments examined will be the current system consisting principally of paramedic management (standard care) compared with management by a retrieval team lead by a consultant anaesthetist, emergency physician or intensive care specialist.
Patients for inclusion in the study will be identified by a paramedic screening all "000" calls to the ambulance service and identifying persons likely to have severe head injury.
The principal outcome measure will be their degree of disability measured at 6 months post injury.
Study Type
Interventional
Enrollment (Actual)
338
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2145
- CareFlight, PO Box 159
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Exclusion Criteria:
- Penetrating trauma
- Age less than 16 years
- No more than 5 casualties at the scene
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard (paramedic) prehospital care
|
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
|
|
Experimental: Physician prehospital care
|
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glasgow Outcome Scale Score
Time Frame: Six months post injury
|
Six months post injury
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of hospital and intensive care unit stays
Time Frame: At hospital discharge
|
At hospital discharge
|
|
30 day survival and survival to discharge from the acute care hospital
Time Frame: At hospital discharge and 30 days
|
At hospital discharge and 30 days
|
|
Extended Glasgow Outcome Scale Score
Time Frame: Six months post injury
|
Six months post injury
|
|
Disability Rating scale
Time Frame: Six months post injury
|
Six months post injury
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alan A Garner, FACEM, CareFlight
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garner AA, Mann KP, Fearnside M, Poynter E, Gebski V. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only. Emerg Med J. 2015 Nov;32(11):869-75. doi: 10.1136/emermed-2014-204390. Epub 2015 Mar 20.
- Garner AA, Fearnside M, Gebski V. The study protocol for the Head Injury Retrieval Trial (HIRT): a single centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics. Scand J Trauma Resusc Emerg Med. 2013 Sep 14;21:69. doi: 10.1186/1757-7241-21-69.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
June 2, 2005
First Submitted That Met QC Criteria
June 2, 2005
First Posted (Estimate)
June 3, 2005
Study Record Updates
Last Update Posted (Estimate)
March 12, 2013
Last Update Submitted That Met QC Criteria
March 10, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIRT1
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