Status:
COMPLETED
A Evaluation Of Biomarkers Associated With Sports Induced Concussions In College Student Athletes
Lead Sponsor:
Banyan Biomarkers, Inc
Conditions:
Traumatic Brain Injury
Sports Concussion
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to study the biomarkers in subjects before and after sports-induced traumatic brain injury. The assay will be studied in a sample population of subjects over the age of 18...
Detailed Description
Concussion or mild traumatic brain injury (mTBI) is a condition that affects hundreds of thousands of patients worldwide. It is a biomechanically induced neurological injury, resulting in an alteratio...
Eligibility Criteria
Inclusion
- The subject is a University of Florida student athlete on a team participating in the study
- The Subject is at least 18 years of age at screening (has had their 18th birthday)
- The Subject is willing to undergo the Informed Consent process prior to enrollment into this study.
- It is the Principal Investigator's opinion that based on the knowledge of the Subject that the Subject is an appropriate candidate for the study.
Exclusion
- Participating in another clinical study that may affect the results of either study.
- Venipuncture not feasible (i.e. skin integrity compromised at the venipuncture sites, blood vessel calcification.
- Not available for the end of season follow-up visit.
- The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this study.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT01472042
Start Date
November 1 2011
End Date
July 1 2015
Last Update
July 20 2016
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610