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Head Injury Retrieval Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00112398
Recruitment Status : Terminated (Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care)
First Posted : June 3, 2005
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
NSW Motor Accident Authority
Information provided by (Responsible Party):
Alan Garner, CareFlight

Tracking Information
First Submitted Date  ICMJE June 2, 2005
First Posted Date  ICMJE June 3, 2005
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE May 2005
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2013)
Glasgow Outcome Scale Score [ Time Frame: Six months post injury ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Glasgow Outcome Scale Score at 6 months post injury
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2013)
  • Length of hospital and intensive care unit stays [ Time Frame: At hospital discharge ]
  • 30 day survival and survival to discharge from the acute care hospital [ Time Frame: At hospital discharge and 30 days ]
  • Extended Glasgow Outcome Scale Score [ Time Frame: Six months post injury ]
  • Disability Rating scale [ Time Frame: Six months post injury ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Length of hospital and intensive care unit stays
  • 30 day survival and survival to discharge from the acute care hospital
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Head Injury Retrieval Trial
Official Title  ICMJE Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Head Injuries, Closed
Intervention  ICMJE Procedure: Extended interventions by advanced level prehospital providers
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2013)
338
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
510
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00112398
Other Study ID Numbers  ICMJE HIRT1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Garner, CareFlight
Study Sponsor  ICMJE CareFlight
Collaborators  ICMJE NSW Motor Accident Authority
Investigators  ICMJE
Principal Investigator: Alan A Garner, FACEM CareFlight
PRS Account CareFlight
Verification Date March 2013

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