NCT00112398

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

6.3 years

First QC Date

June 2, 2005

Last Update Submit

March 10, 2013

Conditions

Head Injuries, Closed

Keywords

Head injuriesPrehospitalAdvanced Interventions

Outcome Measures

Primary Outcomes (1)

  • Glasgow Outcome Scale Score

    Six months post injury

Secondary Outcomes (4)

  • 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

Study Arms (2)

Standard (paramedic) prehospital care

ACTIVE COMPARATOR
Procedure: Extended interventions by advanced level prehospital providers

Physician prehospital care

EXPERIMENTAL
Procedure: Extended interventions by advanced level prehospital providers

Interventions

Extended interventions by advanced level prehospital providersPROCEDURE

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

Physician prehospital careStandard (paramedic) prehospital care

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Penetrating trauma
  • Age less than 16 years
  • No more than 5 casualties at the scene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CareFlight, PO Box 159

Sydney, New South Wales, 2145, Australia

Location

Related Publications (2)

  • 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.

    PMID: 25795741DERIVED

  • 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.

    PMID: 24034628DERIVED

MeSH Terms

Conditions

Head Injuries, ClosedCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Alan A Garner, FACEM

    CareFlight

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

June 2, 2005

First Posted

June 3, 2005

Study Start

May 1, 2005

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

AU(1)