NCT01603537

Brief Summary

Trauma is the leading cause of death among persons below 60 years of age. It is a well-established belief that optimal treatment in the early phase after trauma has a major impact on mortality, and the implementation of specific educational programs for trauma care have been a widely adopted strategy aimed at improving the outcome. This strategy has high face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of the leading educational programs for prehospital emergency trauma care. However, the scientific support for improved patient outcome from courses such as PHTLS and ATLS is limited. According to a Cochrane analysis published 2010 there is no evidence to recommend advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis concerning ATLS gave similar results and a recent study indicated even worsened outcome after the implementation of ATLS. An observational study in the county of Uppsala indicated reduced mortality after the implementation of PHTLS but the estimate was uncertain due to a low overall mortality. The aim of this study is to further investigate the association between PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study population. To accomplish this the investigators will use an epidemiological semi-individual design applied to all victims of traffic injury that occurred during the implementation period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will be analyzed: Mortality before hospital admission, mortality within 30 days, time to death among survivors to hospital admission and return to work among survivors to hospital discharge.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

May 15, 2012

Last Update Submit

May 18, 2012

Conditions

Keywords

Traumatic injuriesPrehospital Trauma Life SupportTraffic accidents

Outcome Measures

Primary Outcomes (4)

  • Mortality before hospital admission.

    Injury deaths not associated with a hospital admission.

    Patients will be followed up to death or at least one year after inclusion.

  • Mortality within 30 days.

    Deaths within 30 days including all deaths, prehospital and hospital, up to 30 days from the injury event.

    Patients will be followed up to death or at least one year after inclusion.

  • Time to death among survivors to hospital admission.

    Time to death among patients associated with a hospital admission.

    Patients will be followed up to death or at least one year after inclusion.

  • Return to work among survivors to hospital discharge.

    Number of patients returned to work per time-unit of observation after the injury event among all patients discharged from hospital, not dead, and that was working before the accident.

    Patients will be followed up to occured event or at least one year after inclusion.

Study Arms (2)

PHTLS

The exposure is defined from the dichotomization of the probability in each event/accident that at least one of the caring ambulance crew members was PHTLS certified.

No PHTLS

Not exposed to PHTLS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study Population: Motor vehicle traffic crashes were selected using the causes of injury matrix developed by the National Center for Health Statistics, Centers for Disease Control and Prevention, USA.

You may qualify if:

  • Primary incident hospital admissions due to traffic accidents or
  • Death due to traffic accidents

You may not qualify if:

  • If a patient appears more than once, all but the first event will be excluded from the dataset.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, County of Uppsala, 754 05, Sweden

Location

Related Publications (8)

  • Krug EG, Sharma GK, Lozano R. The global burden of injuries. Am J Public Health. 2000 Apr;90(4):523-6. doi: 10.2105/ajph.90.4.523.

    PMID: 10754963BACKGROUND
  • Trunkey DD, Lim RC Jr, Blaisdell FW. Traumatic injury. A health care crisis. West J Med. 1974 Jan;120(1):92-4. No abstract available.

    PMID: 4812216BACKGROUND
  • Collicott PE, Hughes I. Training in advanced trauma life support. JAMA. 1980 Mar 21;243(11):1156-9.

    PMID: 7359667BACKGROUND
  • Jayaraman S, Sethi D. Advanced trauma life support training for ambulance crews. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003109. doi: 10.1002/14651858.CD003109.pub2.

    PMID: 20091538BACKGROUND
  • Jayaraman S, Sethi D. Advanced trauma life support training for hospital staff. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004173. doi: 10.1002/14651858.CD004173.pub3.

    PMID: 19370594BACKGROUND
  • Drimousis PG, Theodorou D, Toutouzas K, Stergiopoulos S, Delicha EM, Giannopoulos P, Larentzakis A, Katsaragakis S. Advanced Trauma Life Support certified physicians in a non trauma system setting: is it enough? Resuscitation. 2011 Feb;82(2):180-4. doi: 10.1016/j.resuscitation.2010.10.005. Epub 2010 Nov 30.

    PMID: 21122975BACKGROUND
  • Johansson J, Blomberg H, Svennblad B, Wernroth L, Melhus H, Byberg L, Michaelsson K, Karlsten R, Gedeborg R. Prehospital Trauma Life Support (PHTLS) training of ambulance caregivers and impact on survival of trauma victims. Resuscitation. 2012 Oct;83(10):1259-64. doi: 10.1016/j.resuscitation.2012.02.018. Epub 2012 Feb 23.

    PMID: 22366502BACKGROUND
  • Recommended framework for presenting injury mortality data. MMWR Recomm Rep. 1997 Aug 29;46(RR-14):1-30.

    PMID: 9301976BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Rolf Gedeborg, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of the ambulance service

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 23, 2012

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations