Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries (IDART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773614
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
University of Oslo
Norwegian National Trauma Registry
Norwegian National Advisory Unit on Trauma
Norwegian Public Roads Administration
Norwegian Directorate of Health
Norwegian Ministry of Transport and Communications
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Thomas Kristiansen, 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.


Condition or disease
Trauma Injury

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 8000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Weeks
Official Title: Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries - a National Study on Injury Prevention
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Presence of alcohol in blood samples. [ Time Frame: 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.

  2. Presence of impairing illicit and medicinal drugs in blood samples. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All trauma patients received by trauma team at any Norwegian trauma hospital during the study period.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age
  • foreign citizens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773614


Contacts
Layout table for location contacts
Contact: Thomas Kristiansen, MD, PhD (+47) 23070000 idart@ous-hf.no

Locations
Layout table for location information
Norway
OsloUH Recruiting
Oslo, Norway, 0372
Contact: Thomas Kristiansen, MD, PhD    23070000 ext +47    idart@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Norwegian National Trauma Registry
Norwegian National Advisory Unit on Trauma
Norwegian Public Roads Administration
Norwegian Directorate of Health
Norwegian Ministry of Transport and Communications
Sykehuset Innlandet HF
Additional Information:

Layout table for additonal information
Responsible Party: Thomas Kristiansen, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03773614    
Other Study ID Numbers: 2017/1363
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries