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Head Injury Retrieval Trial

Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00112398
Enrollment
338
Registered
2005-06-03
Start date
2005-05-31
Completion date
2011-09-30
Last updated
2013-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injuries, Closed

Keywords

Head injuries, Prehospital, Advanced Interventions

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.

Interventions

PROCEDUREExtended interventions by advanced level prehospital providers

may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.

Sponsors

NSW Motor Accident Authority
CollaboratorUNKNOWN
CareFlight
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Glasgow Outcome Scale ScoreSix months post injury

Secondary

MeasureTime frame
Length of hospital and intensive care unit staysAt hospital discharge
30 day survival and survival to discharge from the acute care hospitalAt hospital discharge and 30 days
Extended Glasgow Outcome Scale ScoreSix months post injury
Disability Rating scaleSix months post injury

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026