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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
History of Changes
  Purpose

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.


Condition Intervention
Head Injuries, Closed
 Procedure: Extended interventions by advanced level prehospital providers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CareFlight:

Primary Outcome Measures:
  • Glasgow Outcome Scale Score [ Time Frame: Six months post injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 338
Study Start Date: May 2005
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard (paramedic) prehospital care Procedure: Extended interventions by advanced level prehospital providers
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
Experimental: Physician prehospital care Procedure: 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112398

Locations
Australia, New South Wales
CareFlight, PO Box 159
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
CareFlight
NSW Motor Accident Authority
Investigators
Principal Investigator: Alan A Garner, FACEM CareFlight
  More Information

No publications provided

Responsible Party: Alan Garner, Medical Director, CareFlight
ClinicalTrials.gov Identifier: NCT00112398     History of Changes
Other Study ID Numbers: HIRT1
Study First Received: June 2, 2005
Last Updated: March 10, 2013
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by CareFlight:
Head injuries
Prehospital
Advanced Interventions

Additional relevant MeSH terms:
Craniocerebral Trauma
Head Injuries, Closed
Trauma, Nervous System
 Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on May 16, 2013