Head Injury Retrieval Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head Injuries, Closed

Intervention / Treatment
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* Procedure: Extended interventions by advanced level prehospital providers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard (paramedic) prehospital care<br> | Procedure: Extended interventions by advanced level prehospital providers<br>* may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.<br>|
| Experimental: Physician prehospital care<br> | Procedure: Extended interventions by advanced level prehospital providers<br>* may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale Score |  | Six months post injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head injuries, Prehospital, Advanced Interventions