Clinical trial NCT00112398: Head Injury Retrieval Trial
Official title: Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head Injuries, Closed
Keywords: Head injuries
Prehospital
Advanced Interventions
Lead sponsor: CareFlight
Sponsor class: OTHER
Collaborators: name: NSW Motor Accident Authority
First posted: 2005-06-03
Enrollment: 338
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glasgow Outcome Scale Score
timeFrame: Six months post injury
Secondary outcomes:
measure: Length of hospital and intensive care unit stays
timeFrame: At hospital discharge
measure: 30 day survival and survival to discharge from the acute care hospital
timeFrame: At hospital discharge and 30 days
measure: Extended Glasgow Outcome Scale Score
timeFrame: Six months post injury
measure: Disability Rating scale
timeFrame: Six months post injury
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: CareFlight, PO Box 159
state: New South Wales
Study officials:
affiliation: CareFlight
name: Alan A Garner, FACEM
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.