NCT06365944

Brief 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 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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

March 29, 2024

Last Update Submit

April 22, 2024

Conditions

Keywords

Sport-related ConcussionHandballEpidemiology

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 0

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Any refusal to participate
  • Inability to respond

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Helene CASSOUDESALLE

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 15, 2024

Study Start

April 20, 2024

Primary Completion

April 20, 2026

Study Completion

April 20, 2026

Last Updated

April 24, 2024

Record last verified: 2024-04

Locations