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Completed

NCT Number: NCT02175862

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

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.

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Key information

Conditions

Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • TrygFonden, Denmark

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2014
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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