Traumatic Brain InjuryNCT01884103
Field Triage of Older Adults Who Experience Traumatic Brain Injury
An observational study of Traumatic Brain Injury and TBI, run by University of Rochester.
Trial summary
Our overall goal in this proposed study is to describe the current prehospital trauma triage process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to identify the effect of certain medications (anticoagulants and platelet inhibitors) on TBI-related need for trauma center services, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, TBI
- How many people
- 4,533 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Sep 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Emergency Medical Service (EMS) providers who transport injured older adult patients to any of the participating Emergency Departments in Rochester, NY.
Who may be able to join
- EMS Provider arriving with a patient who is injured >=55 years old
Who cannot join
- No systematic exclusions
About this study
Our overall goal in this proposed study is to describe the current prehospital trauma triage process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to identify the effect of certain medications (anticoagulants and platelet inhibitors) on TBI-related need for trauma center services, and to identify novel TBI screening strategies that are feasible for use in the prehospital setting.
Read the detailed description
Traumatic brain injury (TBI) is major source of disability and death for older adults. Of particular concern is that older adults most frequently sustain TBIs after low-mechanism injuries, such as falls from standing height, and frequently use anticoagulants and platelet inhibitors, which place them at risk for worse clinical outcomes. With the growth of the older adult population and the expanding use of anticoagulants and platelet inhibitors, TBI among older adults will continue to be a major source of morbidity and mortality unless methods are identified to improve outcomes in this unique population.
Building upon our long-standing and highly successful EMS research laboratory that has specifically focused on the triage of injured patients and the prehospital care of older patients and employing a combination of qualitative and quantitative methods, we will collect data from a large, multi-county catchment area that includes multiple EMS agencies, urban and rural environments, as well as trauma centers and non-trauma centers. In this study, we will: 1) identify candidate neurologic scales to maximize detection of high-risk older adult TBI patients; 2) characterize the current trauma triage process used by EMS providers to identify older patients with suspected TBI and patients taking anticoagulants and/or platelet inhibitors; 3) assess the public health burden of TBI among older adult EMS patients taking anticoagulants and/or platelet inhibitors; 4) assess the predictive ability of novel prehospital-based neurologic screening strategies to identify high-risk older adult TBI patients in the prehospital setting who require TBI-related trauma center care. Findings from this study have the potential to shift clinical practice in the prehospital setting by informing future recommendations for the identification of TBI among older adults taking anticoagulants or platelet inhibitors.
- Conditions
- Traumatic Brain Injury, TBI
- Keywords
- TBI, Trauma, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EMS Providers | Field Triage Decision-making for older adult patients with potential TBI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of older adult EMS patients taking anticoagulants and/or platelet inhibitors who require TBI-related trauma center care.
Measured: Within 72 hrs of initiating EMS care
Sensitivity, specificity and overall classification accuracy of selected neurologic scales (including GCS, and a newly developed scale) used in the prehospital setting to maximize detection of high-risk older TBI patients.
Measured: Within 72 hrs of initiating EMS care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manish Shah, University of Rochester
- Investigators
- Manish Shah, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884103
- Sponsor's protocol ID
- 1U01CE002175
- Status last verified
- Sep 2016
- First submitted
- 13 Jun 2013
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Triage of Older Adults Who Experience Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01884103
- Acronym / sponsor ID
- 1U01CE002175
- Conditions
- Traumatic Brain Injury, TBI
- Keywords
- TBI, Trauma, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,533 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 21 Jun 2013 (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.
Our overall goal in this proposed study is to describe the current prehospital trauma triage process for older adult (age≥55) patients with suspected Traumatic Brain Injury (TBI), to identify the effect of certain medications (anticoagulants and platelet inhibitors) on TBI-related need for trauma center services, and to identify novel TBI screening strategies that are feasible for use in the prehospital setting.
Detailed description
Traumatic brain injury (TBI) is major source of disability and death for older adults. Of particular concern is that older adults most frequently sustain TBIs after low-mechanism injuries, such as falls from standing height, and frequently use anticoagulants and platelet inhibitors, which place them at risk for worse clinical outcomes. With the growth of the older adult population and the expanding use of anticoagulants and platelet inhibitors, TBI among older adults will continue to be a major source of morbidity and mortality unless methods are identified to improve outcomes in this unique population.
Building upon our long-standing and highly successful EMS research laboratory that has specifically focused on the triage of injured patients and the prehospital care of older patients and employing a combination of qualitative and quantitative methods, we will collect data from a large, multi-county catchment area that includes multiple EMS agencies, urban and rural environments, as well as trauma centers and non-trauma centers. In this study, we will: 1) identify candidate neurologic scales to maximize detection of high-risk older adult TBI patients; 2) characterize the current trauma triage process used by EMS providers to identify older patients with suspected TBI and patients taking anticoagulants and/or platelet inhibitors; 3) assess the public health burden of TBI among older adult EMS patients taking anticoagulants and/or platelet inhibitors; 4) assess the predictive ability of novel prehospital-based neurologic screening strategies to identify high-risk older adult TBI patients in the prehospital setting who require TBI-related trauma center care. Findings from this study have the potential to shift clinical practice in the prehospital setting by informing future recommendations for the identification of TBI among older adults taking anticoagulants or platelet inhibitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMS Providers | – | –Field Triage Decision-making for older adult patients with potential TBI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Medical Service (EMS) providers who transport injured older adult patients to any of the participating Emergency Departments in Rochester, NY.
Key inclusion criteria (1 listed)
- EMS Provider arriving with a patient who is injured >=55 years old
Key exclusion criteria (1 listed)
- No systematic exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of older adult EMS patients taking anticoagulants and/or platelet inhibitors who require TBI-related trauma center care.
Time frame: Within 72 hrs of initiating EMS care
Sensitivity, specificity and overall classification accuracy of selected neurologic scales (including GCS, and a newly developed scale) used in the prehospital setting to maximize detection of high-risk older TBI patients.
Time frame: Within 72 hrs of initiating EMS care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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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.
Manish Shah, MD, MPH principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and TBI, run by University of Rochester.
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 1 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: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of older adult EMS patients taking anticoagulants and/or platelet inhibitors who require TBI-related trauma center care. (time frame: Within 72 hrs of initiating EMS care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2016.