Head Injury Retrieval Trial

Not Applicable

Terminated

• Conditions: Head Injuries, Closed

• Registration Number: NCT00112398
• Lead Sponsor: CareFlight

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-06-02
• Study First Submitted QC: 2005-06-02
• Study First Posted: 2005-06-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-10
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 338

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale Score	Six months post injury

Secondary Outcome Measures

Name	Time	Method
Length of hospital and intensive care unit stays	At hospital discharge
30 day survival and survival to discharge from the acute care hospital	At hospital discharge and 30 days
Extended Glasgow Outcome Scale Score	Six months post injury
Disability Rating scale	Six months post injury

Trial Locations

Locations (1)

CareFlight, PO Box 159; 🇦🇺 Sydney, New South Wales, Australia