Field Triage of Older Adults Who Experience Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Field Triage of Older Adults Who Experience Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884103
• Other study ID #: 1U01CE002175
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: September 7, 2016
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Centers for Disease Control
• Study type: Observational

Clinical 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 to identify novel TBI screening strategies that are feasible for use in the prehospital setting.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4533
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• EMS Provider arriving with a patient who is injured >=55 years old

Exclusion Criteria:

• No systematic exclusions

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• TBI
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of older adult EMS patients taking anticoagulants and/or platelet inhibitors who require TBI-related trauma center care.		Within 72 hrs of initiating EMS care	No
Primary	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.		Within 72 hrs of initiating EMS care	No