Health and Road Safety: Influence of Drugs Use and Health Status (CESIR-U2)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Car Accident

Study type

Observational

Funder types

Other

Identifiers

NCT02688504
CHUBX 2012/33

Details and patient eligibility

About

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.

Enrollment

1,200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,200 participants in 2 patient groups

serious road accidents
Description:
Drivers involved in serious road accidents (hospitalization > 24 hours)
non-serious road accidents
Description:
drivers involved in non-serious road accidents (hospitalization < 24 hours).

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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