Head Injuries, ClosedNCT00112398
Head Injury Retrieval Trial
A study testing Extended interventions by advanced level prehospital providers in people with Head Injuries, Closed, run by CareFlight at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Head Injuries, Closed
- What is being tested?
- Extended interventions by advanced level prehospital providers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteAustralia
- Study dates
- May 2005to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Penetrating trauma
- Age less than 16 years
- No more than 5 casualties at the scene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
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.
Read the 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
- Being tested
- Extended interventions by advanced level prehospital providers
- Keywords
- Head injuries, Prehospital, Advanced Interventions
- Medical subject headings
- Head Injuries, Closed, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended interventions by advanced level prehospital providersProcedure or surgery
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
| Study group | Role | What they receive |
|---|---|---|
| Standard (paramedic) prehospital care | Active comparator | Not described Receives: Procedure: Extended interventions by advanced level prehospital providers |
| Physician prehospital care | Experimental | Not described Receives: Procedure: Extended interventions by advanced level prehospital providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale Score
Measured: Six months post injury
Secondary outcomes (4)
Length of hospital and intensive care unit stays
Measured: At hospital discharge
30 day survival and survival to discharge from the acute care hospital
Measured: At hospital discharge and 30 days
Extended Glasgow Outcome Scale Score
Measured: Six months post injury
Disability Rating scale
Measured: Six months post injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head Injuries, ClosedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- CareFlight
- Sponsor type
- University, hospital or other
- Collaborators
- NSW Motor Accident Authority
- Responsible party
- Principal investigator, Alan Garner, CareFlight
- Investigators
- Alan A Garner, FACEM, Principal investigator, CareFlight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112398
- Sponsor's protocol ID
- HIRT1
- Status last verified
- Mar 2013
- First submitted
- 2 Jun 2005
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25795741Garner 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.
PubMed 24034628
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
- ClinicalTrials.gov ID
- NCT00112398
- Acronym / sponsor ID
- HIRT1
- Conditions
- Head Injuries, Closed
- Keywords
- Head injuries, Prehospital, Advanced Interventions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care
- Enrolment
- 338 participants (actual)
- Lead sponsor
- CareFlightUniversity, hospital or other
- Collaborators
- NSW Motor Accident Authority
- Study start
- May 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Penetrating trauma
- Age less than 16 years
- No more than 5 casualties at the scene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended interventions by advanced level prehospital providersmay include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc. | Procedure or surgery | Physician prehospital care, Standard (paramedic) prehospital care |
Primary outcome
Glasgow Outcome Scale Score
Time frame: Six months post injury
4 secondary outcomes
Length of hospital and intensive care unit stays
Time frame: At hospital discharge
30 day survival and survival to discharge from the acute care hospital
Time frame: At hospital discharge and 30 days
Extended Glasgow Outcome Scale Score
Time frame: Six months post injury
Disability Rating scale
Time frame: Six months post injury
Results and safety
The study was stopped early (reason given: Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
- Derived from this study: PubMed 25795741Garner 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.
- Derived from this study: PubMed 24034628Garner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan A Garner, FACEM principal investigator
CareFlight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended interventions by advanced level prehospital providers in people with Head Injuries, Closed, run by CareFlight at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Score (time frame: Six months post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00112398, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.