Brain ConcussionPRECCOCENCT06365944
Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process
An observational study of Brain Concussion and Cerebral Concussion, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Concussion, Cerebral Concussion
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2024to 20 Apr 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is descriptive, prospective, with a questionnaire sent off to any player, above 18 years old, male or female, that had receive a white card during an official match in the French amateur Handball league along two regular season.During an official game, if the referee issues a white card, the player is then contacted by the French Handball Federation (FFHB) via an email in a day.
Who may be able to join
- Male or female
- Over 18 years old
- Who had received a white card during an official game
- having an email address registered in the FFHB register
Who cannot join
- Any refusal to participate
- Inability to respond
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bordeaux University Hospital
Bordeaux
Quentin LHUAIRE
About this study
Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.
Read the detailed description
Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. The short, medium and long-term issues of such impact are still debated but some studies have pointed the fact that acute concussion, repetitive concussions, and even "sub-concussive" impacts could major the risk of developing brain diseases and cognitive impairments. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.
This study will be an epidemiological descriptive and prospective study with a brief questionnaire sent off to any player, above 18 years old, male or female, that had receive a white card during an official match in the French amateur Handball league along two regular season. The results will bring details on how concussion occurs on field and how this protocol is efficient to bring the player to consult a health professional.
- Conditions
- Brain Concussion, Cerebral Concussion
- Keywords
- Sport-related Concussion, Handball, Epidemiology
- Medical subject headings
- Brain Concussion
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire)
Risk of concussion estimated by questionnaire collecting the following informations :
- Sport Concussion Assessment Tool 6 (SCAT6)'s 22 symptoms, each symptoms is scales from 0 to 6, 6 being the highest intensity of the symptom.
Having > 1 in at least two different symptoms is considered at risk of having a concussion
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start20 Apr 2024
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene CASSOUDESALLE, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365944
- Sponsor's protocol ID
- CHUBX 2023/73
- Acronym
- PRECCOCE
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process
- ClinicalTrials.gov ID
- NCT06365944
- Acronym / sponsor ID
- PRECCOCE / CHUBX 2023/73
- Conditions
- Brain Concussion, Cerebral Concussion
- Keywords
- Sport-related Concussion, Handball, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- 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.
Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.
Detailed description
Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. The short, medium and long-term issues of such impact are still debated but some studies have pointed the fact that acute concussion, repetitive concussions, and even "sub-concussive" impacts could major the risk of developing brain diseases and cognitive impairments. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol.
This study will be an epidemiological descriptive and prospective study with a brief questionnaire sent off to any player, above 18 years old, male or female, that had receive a white card during an official match in the French amateur Handball league along two regular season. The results will bring details on how concussion occurs on field and how this protocol is efficient to bring the player to consult a health professional.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is descriptive, prospective, with a questionnaire sent off to any player, above 18 years old, male or female, that had receive a white card during an official match in the French amateur Handball league along two regular season.During an official game, if the referee issues a white card, the player is then contacted by the French Handball Federation (FFHB) via an email in a day.
Key inclusion criteria (4 listed)
- Male or female
- Over 18 years old
- Who had received a white card during an official game
- having an email address registered in the FFHB register
Key exclusion criteria (2 listed)
- Any refusal to participate
- Inability to respond
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire)
Time frame: Day 0
Risk of concussion estimated by questionnaire collecting the following informations : - Sport Concussion Assessment Tool 6 (SCAT6)'s 22 symptoms, each symptoms is scales from 0 to 6, 6 being the highest intensity of the symptom. Having > 1 in at least two different symptoms is considered at risk of having a concussion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
Related trials for Brain Concussion
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Helene CASSOUDESALLE principal investigator
University Hospital, Bordeaux
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 Brain Concussion and Cerebral Concussion, run by University Hospital, Bordeaux 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 4 inclusion and 2 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 24 Apr 2024. 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 Quentin LHUAIRE (05 56 79 55 46 ext. +33, quentin.lhuaire@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire) (time frame: Day 0). 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 24 Apr 2024.