Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries

NCT03773614 | Completed

• 1 other identifier: 2017/1363
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Injury

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All trauma patients received by trauma team at any Norwegian trauma hospital during the study period.

You may qualify if:

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

You may not qualify if:

• age
• foreign citizens

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Norwegian National Trauma Registry: collaborator
• Norwegian National Advisory Unit on Trauma: collaborator
• Norwegian Public Roads Administration: collaborator
• Norwegian Directorate of Health: collaborator
• Norwegian Ministry of Transport and Communications: collaborator
• Sykehuset Innlandet HF: collaborator

Study Sites (1)

OsloUH

Oslo, 0372, Norway

Location

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: December 12, 2018
• Study Start: March 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

NO (1)