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Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter

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ClinicalTrials.gov Identifier: NCT02175862
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Kamilia S. Funder, Rigshospitalet, Denmark

Brief Summary:

In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS) was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.

In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus Hesselfeldt, conducted an observational study to investigate the possible effects on time to definitive care, secondary transfers and 30-day mortality in a "before" and "after" design.

Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day mortality significantly reduced from 29 % to 14 % in the year after implementation.

The present study is an observational cohort study with long-term follow-up of the same trauma population as mentioned above. Patients were followed until may 1st, 2014.

Primary outcome is early retirement and secondary outcomes are quality of life and mortality.

The investigators hypothesize that a greater proportion of trauma patients in the "after" period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients treated in the "before" period.


Condition or disease
Wounds and Injuries

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1791 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter
Study Start Date : December 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Trauma patients before PS-HEMS
The "before" period was between december 1 2009 to april 30 2010 (five months).
Traume patients after PS-HEMS
The "after" period was between may 1 2010 to april 30 2011 (12 months).



Primary Outcome Measures :
  1. Labor market attachment [ Time Frame: 3 - 4.5 years after trauma ]
    Primary analysis: Risk of early retirement Secondary analysis: Risk of reduced work capability


Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 3 - 4.5 years after trauma ]
    Health-related quality of life is measured using the Danish version of the Short Form 36 (SF-36) questionaire.

  2. All cause mortality [ Time Frame: 3 - 4.5 years after trauma ]
    Primary analysis: Risk of death. Secondary analysis: Predictors of death



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All trauma patients treated in the catchment area of PS-HEMS in a 17-month period from 1 December 2009 to 30 April 2011 (1791 patients).
Criteria

Inclusion Criteria:

  • Patients treated by a trauma team in the catchment area of PS-HEMS.

For all labor market attachment analysis the investigators only include patients between 18 to 60 years of age. For all other analysis (mortality and quality of life) there are no age limits.

Exclusion Criteria:

  • Patients transported by private means or by the police.
  • Patients who at the emergency department were categorized as non-trauma patients.

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): NCT02175862


Locations
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Denmark
Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
Investigators
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Principal Investigator: Kamilia S. Funder, MD Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Study Director: Jacob Steinmetz, MD, PhD Trauma Center, Copenhagen University Hospital, Rigshospitalet
Additional Information:

Publications:

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Responsible Party: Kamilia S. Funder, MD., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02175862    
Other Study ID Numbers: ALH1-KF-2014
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Keywords provided by Kamilia S. Funder, Rigshospitalet, Denmark:
Helicopter Emergency Medical Service
Trauma
Early retirement
ISS
Quality of life
Additional relevant MeSH terms:
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Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes