Back to resultsHead Injury Retrieval Trial
Primary Purpose
Head Injuries, Closed
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Extended interventions by advanced level prehospital providers
Sponsored by
About this trial
This is an interventional treatment trial for Head Injuries, Closed focused on measuring Head injuries, Prehospital, Advanced Interventions
Eligibility Criteria
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
Sites / Locations
- CareFlight, PO Box 159
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard (paramedic) prehospital care
Physician prehospital care
Arm Description
Outcomes
Primary Outcome Measures
Glasgow Outcome Scale Score
Secondary Outcome Measures
Length of hospital and intensive care unit stays
30 day survival and survival to discharge from the acute care hospital
Extended Glasgow Outcome Scale Score
Disability Rating scale
Full Information
NCT ID
NCT00112398
First Posted
June 2, 2005
Last Updated
March 10, 2013
Sponsor
CareFlight
Collaborators
NSW Motor Accident Authority
1. Study Identification
Unique Protocol Identification Number
NCT00112398
Brief Title
Head Injury Retrieval Trial
Official Title
Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CareFlight
Collaborators
NSW Motor Accident Authority
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injuries, Closed
Keywords
Head injuries, Prehospital, Advanced Interventions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard (paramedic) prehospital care
Arm Type
Active Comparator
Arm Title
Physician prehospital care
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Extended interventions by advanced level prehospital providers
Intervention Description
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
Primary Outcome Measure Information:
Title
Glasgow Outcome Scale Score
Time Frame
Six months post injury
Secondary Outcome Measure Information:
Title
Length of hospital and intensive care unit stays
Time Frame
At hospital discharge
Title
30 day survival and survival to discharge from the acute care hospital
Time Frame
At hospital discharge and 30 days
Title
Extended Glasgow Outcome Scale Score
Time Frame
Six months post injury
Title
Disability Rating scale
Time Frame
Six months post injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan A Garner, FACEM
Organizational Affiliation
CareFlight
Official's Role
Principal Investigator
Facility Information:
Facility Name
CareFlight, PO Box 159
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25795741
Citation
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.
Results Reference
derived
PubMed Identifier
24034628
Citation
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.
Results Reference
derived
Learn more about this trial
Head Injury Retrieval Trial
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