Health and Road Safety: Influence of Drugs Use and Health Status

Car Accident Clinical Trial

— CESIR-U2  

Official title:

CESIR-U2 : Influence of Drugs Use and Health Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688504
• Other study ID #: CHUBX 2012/33
• Status: Completed
• Start date: October 18, 2016
• Est. completion date: December 26, 2018

Study information

• Verified date: May 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.

When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.

This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.

This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization < 24 hours) that represent around 73% of accidents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 26, 2018
• Est. primary completion date: December 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Driver involved in a road accident and admitted in an emergency department

• Aged over 18 years

• Able to respond to a structured questionnaire

• Having agreed to participate in the study

Exclusion Criteria:

• Minors

• Passenger

• Pedestrian

• Discharge or transfer to another hospital/clinic before the interview

Related Conditions & MeSH terms

• Car Accident

Locations

Country	Name	City	State
France	Hôpital Pellegrin	Bordeaux
France	CH de Perigueux	Périgueux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drugs use reported by drivers involved in road accidents	Drugs use is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who take drugs, by ATC classification, by pictogram and by drug.	inclusion date
Secondary	Responsibility of the driver for the accident	The responsibility of the driver (responsible or not responsible) is a data extracted from the BAAC sheet (a sheet fulfilled by the police in case of traffic crashes)	inclusion date
Secondary	Seriousness of the accident	The seriousness of the accident is assessed according the duration of hospital stay. If the duration is less than 24 hours, accidents are considered as non serious. If not, accidents are considered as serious.	inclusion date
Secondary	Knowledge of drivers about graded pictogram featured on drugs packaging	Knowledge about graded pictogram is collected during a structured interview administered by a trained CRA. Measure title : percentage of drivers who know if a pictogram is featured on their drugs packagings.	inclusion date