Head Injury Retrieval Trial

Head Injuries, Closed Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00112398
• Other study ID #: HIRT1
• Status: Terminated
• Phase: N/A
• First received: June 2, 2005
• Last updated: March 10, 2013
• Start date: May 2005
• Est. completion date: September 2011

Study information

• Verified date: March 2013
• Source: CareFlight
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 338
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injuries, Closed

Intervention

Procedure:
• Extended interventions by advanced level prehospital providers
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.

Locations

Country	Name	City	State
Australia	CareFlight, PO Box 159	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
CareFlight	NSW Motor Accident Authority

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale Score		Six months post injury	No
Secondary	Length of hospital and intensive care unit stays		At hospital discharge	No
Secondary	30 day survival and survival to discharge from the acute care hospital		At hospital discharge and 30 days	No
Secondary	Extended Glasgow Outcome Scale Score		Six months post injury	No
Secondary	Disability Rating scale		Six months post injury	No