Head Injury Retrieval Trial

This study has been terminated.
(Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care)
Sponsor:
Collaborator:
NSW Motor Accident Authority
Information provided by (Responsible Party):
Alan Garner, CareFlight
ClinicalTrials.gov Identifier:
NCT00112398
First received: June 2, 2005
Last updated: March 10, 2013
Last verified: March 2013

June 2, 2005
March 10, 2013
May 2005
September 2011   (final data collection date for primary outcome measure)
Glasgow Outcome Scale Score [ Time Frame: Six months post injury ] [ Designated as safety issue: No ]
Glasgow Outcome Scale Score at 6 months post injury
Complete list of historical versions of study NCT00112398 on ClinicalTrials.gov Archive Site
  • Length of hospital and intensive care unit stays [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]
  • 30 day survival and survival to discharge from the acute care hospital [ Time Frame: At hospital discharge and 30 days ] [ Designated as safety issue: No ]
  • Extended Glasgow Outcome Scale Score [ Time Frame: Six months post injury ] [ Designated as safety issue: No ]
  • Disability Rating scale [ Time Frame: Six months post injury ] [ Designated as safety issue: No ]
  • Length of hospital and intensive care unit stays
  • 30 day survival and survival to discharge from the acute care hospital
Not Provided
Not Provided
 
Head Injury Retrieval Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Head Injuries, Closed
Procedure: Extended interventions by advanced level prehospital providers
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
  • Active Comparator: Standard (paramedic) prehospital care
    Intervention: Procedure: Extended interventions by advanced level prehospital providers
  • Experimental: Physician prehospital care
    Intervention: Procedure: Extended interventions by advanced level prehospital providers
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
338
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00112398
HIRT1
Yes
Alan Garner, CareFlight
CareFlight
NSW Motor Accident Authority
Principal Investigator: Alan A Garner, FACEM CareFlight
CareFlight
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP