Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries

Trauma Injury Clinical Trial

— IDART  

Official title:

Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries - a National Study on Injury Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773614
• Other study ID #: 2017/1363
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: June 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• age

• foreign citizens

Related Conditions & MeSH terms

• Trauma Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Norway	OsloUH	Oslo

Sponsors (8)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Directorate of Health, Norwegian Ministry of Transport and Communications, Norwegian National Advisory Unit on Trauma, Norwegian National Trauma Registry, Norwegian Public Roads Administration, Sykehuset Innlandet HF, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of alcohol in blood samples.	Alcohol is reported in grams per liter. Analysis of alcohol is performed with an automated enzymatic method using alcohol dehydrogenase.	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.
Primary	Presence of impairing illicit and medicinal drugs in blood samples.	Impairing substances are reported as nanogram per milliliter. Analysis is performed using liquid chromatography coupled with mass spectrometry.	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.