- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02930395
Blood Biomarkers for the Management of Concussion in Professional Rugby Players (RUGBYPROS100B)
October 13, 2016 updated by: University Hospital, Clermont-Ferrand
In the past 20 years, the incidence of concussion in direct contact sports has significantly increased.
The incidence of concussion in rugby players ranges between 8 to 17 episodes / 1000 playing hours.
A recent study published by the French Rugby Federation (FFR) and the National Rugby League (LNR) showed similar results.
The latter study was performed analyzing the French "TOP14", which includes 14 teams participating in professional rugby championships.
At least two concussions were diagnosed each week.
Despite the recent evidence, cognitive assessment remains the only means to determine whether or not players experiencing concussions can return to the game or not.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The possible evolution of neuro-vascular damage and its biological consequences are currently overlooked.
The Head Injury Assessment (HIA) is the current gold standard used by the national Rugby Medical Authorities in accordance with international safety protocols.
The HIA protocol relies on neurological or neuropsychological endpoints, potentially subjective or not ensuring sufficient sensitivity.
As a result, defining the immediate and long-term pathophysiological consequences of concussions remains challenging.
The introduction of an objective blood test to detect the presence and the evolution overtime of neuro-vascular damage could represent a pairing approach filling a sensitive gap in the management of concussed players.
Recent evidence has proposed the use of serum biomarkers aiding post-concussion management .
Remarkably, serum biomarkers of neuro-vascular functions are currently being used in emergency room settings.
Serum levels of the brain protein S100β were demonstrated to have an excellent negative predictive value for neurovascular damage after mild traumatic brain injury (mTBI).
Measurement of blood S100β was proposed as a tool to grade TBI, limiting unnecessary CT scan examinations in emergency cases .
However, whether the use of serum makers of neuro-vascular damage could benefit the management of sport-related concussion remains unclear.
Moreover, repeated concussions have been linked to an increased risk of Alzheimer's disease, Multiple Sclerosis and Parkinson's disease .
Serum biomarkers could be of diagnostic and prognostic value, facilitating return to play decisions or predicting lingering risks of cognitive decline.
Study Type
Observational
Enrollment (Anticipated)
560
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Clermont-Ferrand, France, 63003
- CHU Clermont-Ferrand
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Principal Investigator:
- Vincent SAPIN
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Professional rugby players
Description
Inclusion Criteria:
- Players age > 18 years old.
- Players routinely managed by the medical staff of collaborative rugby teams. Availability of clinical data, age, body mass index, brain performance, previous HIA scores, history of concussions.
- Players must agree with all of the aspects of the research. Players must consent for a baseline blood draw before the season starts and follow up sampling after concussions
Exclusion Criteria:
- Adverse players' life style (e.g., alcohol consumption, medications or chronic drug regimens) or pathological conditions associated with abnormal S100β levels (e.g., S100 genetic variants, cutaneous infections, brain tumor, auto-immune disorders, or hyper-lymphocytosis).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
professional rugby players
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
significance of S100β/HIA score in the early management of concussion
Time Frame: at day 1
|
at day 1
|
significance of unveiling novel markers of long-term brain cell damage in rugby players
Time Frame: at day 1
|
at day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Vincent SAPIN, University Hospital, Clermont-Ferrand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (ANTICIPATED)
October 1, 2017
Study Completion (ANTICIPATED)
November 1, 2017
Study Registration Dates
First Submitted
October 10, 2016
First Submitted That Met QC Criteria
October 10, 2016
First Posted (ESTIMATE)
October 12, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHU-0282
- DC-2016-2742 (OTHER: DC-2016-2742)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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