NCT01884103

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,533

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Status
completed

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

June 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

June 13, 2013

Last Update Submit

September 7, 2016

Conditions

Traumatic Brain InjuryTBI

Keywords

TBITraumaTraumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

EMS Providers

Field Triage Decision-making for older adult patients with potential TBI.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency Medical Service (EMS) providers who transport injured older adult patients to any of the participating Emergency Departments in Rochester, NY.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous System

Study Officials

  • Manish Shah, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine, Public Health Sciences, and Geriatrics

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 21, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 8, 2016

Record last verified: 2016-09