ConcussionRUGBYPROS100BNCT02930395
Blood Biomarkers for the Management of Concussion in Professional Rugby Players
An observational study of Concussion and Professional TOP14 Rugby Players, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Concussion, Professional TOP14 Rugby Players
- What is being tested?
- serum S100B assay
- Type of treatment
- Surgery or procedure
- How many people
- 560 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Nov 2017
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Professional rugby players
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Vincent SAPIN
About this study
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.
Read the 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.
- Conditions
- Concussion, Professional TOP14 Rugby Players
- Being tested
- serum S100B assay
- Keywords
- Concussion, Professional rugby players, S100B
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum S100B assayProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| professional rugby players | Not described Receives: Procedure: serum S100B assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
significance of S100β/HIA score in the early management of concussion
Measured: at day 1
significance of unveiling novel markers of long-term brain cell damage in rugby players
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- World Rugby Research Unit
- Responsible party
- Sponsor
- Investigators
- Vincent SAPIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930395
- Sponsor's protocol ID
- CHU-0282
- Other IDs
- DC-2016-2742
- Acronym
- RUGBYPROS100B
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Biomarkers for the Management of Concussion in Professional Rugby Players
- ClinicalTrials.gov ID
- NCT02930395
- Acronym / sponsor ID
- RUGBYPROS100B / CHU-0282
- Conditions
- Concussion, Professional TOP14 Rugby Players
- Keywords
- Concussion, Professional rugby players, S100B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- World Rugby Research Unit
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 12 Oct 2016 (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.
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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| professional rugby players | – | Procedure: serum S100B assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Professional rugby players
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum S100B assay | Procedure or surgery | professional rugby players |
Primary outcome
significance of S100β/HIA score in the early management of concussion
Time frame: at day 1
significance of unveiling novel markers of long-term brain cell damage in rugby players
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Utility of S100B Serum Level for the Determination of Concussion in Male Rugby PlayersLink provided by the sponsor.
- Systematic review of clinical studies examining biomarkers of brain injury in athletes after sports-related concussionLink provided by the sponsor.
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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.
Vincent SAPIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion and Professional TOP14 Rugby Players, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significance of S100β/HIA score in the early management of concussion (time frame: at day 1). 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 14 Oct 2016.