Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries

Completed

• Conditions: Trauma Injury

• Registration Number: NCT03773614
• Lead Sponsor: Oslo University Hospital

Brief Summary

Impairing drugs and alcohol are major risk factors for traumatic injuries. Still there is to date little knowledge to what extent these factors affect the epidemiology of trauma. Detailed mapping of risk factors improve targeting and efficiency of primary injury prevention. The aim of this project is therefore to facilitate injury prevention through improved data collection and analysis on impairing drugs and alcohol as a contributing and modifiable factor in injury morbidity and mortality.

Study question: What is the toxicological profile among patients with suspected severe traumatic injury? Study design: a prospective population-based and national observational study will analyse toxicology from blood samples of all trauma admission during a 12 month study period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Study Start: 2019-03-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-18
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• admission to any Norwegian Trauma Hospital (n=37) AND trauma team activation, during study period

Exclusion Criteria

• age
• foreign citizens

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of impairing illicit and medicinal drugs in blood samples.	Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period.	Impairing substances are reported as nanogram per milliliter. Analysis is performed using liquid chromatography coupled with mass spectrometry.
Presence of alcohol in blood samples.	Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period. The database is analyzed after study period is completed.	Alcohol is reported in grams per liter. Analysis of alcohol is performed with an automated enzymatic method using alcohol dehydrogenase.

Trial Locations

Locations (1)

OsloUH; 🇳🇴 Oslo, Norway