Head Injury Retrieval Trial - Full Text View

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

MedlinePlus related topics:

Head and Brain Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by CareFlight:

Primary Outcome Measures:

Glasgow Outcome Scale Score at 6 months post injury

Secondary Outcome Measures:

Length of hospital and intensive care unit stays
30 day survival and survival to discharge from the acute care hospital

Estimated Enrollment:	510
Study Start Date:	May 2005
Estimated Study Completion Date:	November 2008

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	Recruiting
	Sydney, New South Wales, Australia, 2145
	Contact: Alan A Garner, MBBS, MSc + 61 0411024614 alang@careflight.org
	Contact: Ken Harrison, MBBS kenh@nlc.net.au
	Principal Investigator: Alan A Garner, MBBS, FACEM, MSc

Sponsors and Collaborators

CareFlight

Investigators


Principal Investigator:	Alan A Garner, FACEM	CareFlight

More Information

Study ID Numbers:	HIRT1
First Received:	June 2, 2005
Last Updated:	April 16, 2007
ClinicalTrials.gov Identifier:	NCT00112398
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by CareFlight:

Head injuries

Prehospital

Advanced Interventions

Study placed in the following topic categories:

Craniocerebral Trauma

Wounds and Injuries

Disorders of Environmental Origin

Head Injuries, Closed

Wounds, Nonpenetrating

Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	CareFlight
Information provided by:	CareFlight
ClinicalTrials.gov Identifier:	NCT00112398