Head Injury Retrieval Trial

NCT ID: NCT00112398

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2011-09-30

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.

Conditions

Head Injuries, Closed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard (paramedic) prehospital care

Group Type: ACTIVE_COMPARATOR

Extended interventions by advanced level prehospital providers

Intervention Type: PROCEDURE

may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.

Physician prehospital care

Group Type: EXPERIMENTAL

Extended interventions by advanced level prehospital providers

Intervention Type: PROCEDURE

may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.

Interventions

Extended interventions by advanced level prehospital providers

may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NSW Motor Accident Authority

UNKNOWN

Sponsor Role: collaborator

CareFlight

OTHER

Sponsor Role: lead

Responsible Party

Alan Garner

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan A Garner, FACEM

Role: PRINCIPAL_INVESTIGATOR

CareFlight

Locations

CareFlight, PO Box 159

Sydney, New South Wales, Australia

Countries

Australia

References

Garner AA, Mann KP, Fearnside M, Poynter E, Gebski V. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only. Emerg Med J. 2015 Nov;32(11):869-75. doi: 10.1136/emermed-2014-204390. Epub 2015 Mar 20.

Reference Type: DERIVED

PMID: 25795741 (View on PubMed)

Garner AA, Fearnside M, Gebski V. The study protocol for the Head Injury Retrieval Trial (HIRT): a single centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics. Scand J Trauma Resusc Emerg Med. 2013 Sep 14;21:69. doi: 10.1186/1757-7241-21-69.

Reference Type: DERIVED

PMID: 24034628 (View on PubMed)

Other Identifiers

HIRT1

Identifier Type: -

Identifier Source: org_study_id