Clinical trial NCT02576379: The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients
Official title: The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombolysis
Keywords: Helicopter Emergency Medical System
Mortality
Labour market affiliation
Modified Rankin Scale
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 1068
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients arriving at the regional stroke unit at Copenhagen University Hospital, Roskilde, suspected of an acute vascular condition within the geographical area covered by both HEMS and GEMS in a 40-month period from January 1st 2010 until April 30th 2013.

The geographical catchment area is defined as the area from where HEMS transported patients the first year of implementation.

We compare stroke patients transported by HEMS with stroke patients transported by GEMS.

Brief summary: Stroke is a leading cause of death and disability, and 15 million people suffer a stroke each year; one-third die and one-third are left permanently disabled. Because the risk of stroke increases with age, it has been considered a disease of the elderly, but stroke also occurs in middle-aged people.

Thrombolysis with tissue plasminogen activator (tPA) is the preferred choice of reperfusion therapy of ischemic stroke if performed within 4.5 hours from symptom onset. Time to thrombolysis is associated with improved outcome: the sooner the treatment, the less risk of serious - and possibly permanent - damage to the brain. Unfortunately, only a small fraction of stroke patients make it to thrombolysis within the 4.5-hour; one explanation may be system delays including prolonged transportation.

In May 2010, the first physician-staffed Helicopter Emergency Medical Service (HEMS) was implemented in the Eastern part of Denmark. An observational study evaluating the short-term effects of HEMS implementation compared patients transported by conventional ground ambulance (Ground Emergency Medical Service (GEMS)) to patients transported by HEMS. Patients transported by helicopter had increased time to specialized care. However, both 30-day and 1-year mortality was slightly lower in patients transported by HEMS, although not significant, as was the degree of disability at three months measured by the modified Rankin Scale (mRS).


Eligibility criteria: Inclusion Criteria:

* All patients arriving at the regional stroke unit at Copenhagen University Hospital, Roskilde, suspected of an acute vascular condition within the geographical area covered by both HEMS and GEMS in a 40-month period from January 1st 2010 until April 30th 2013.

Exclusion Criteria:

* For patients with multiple contacts; only the first contact is included in the data for analysis.

Primary outcomes:
measure: Risk of death during follow-up
timeFrame: 2 - 5.5 years after admission to the stroke unit.
Secondary outcomes:
measure: The risk of death at 30 day.
timeFrame: 30 days after admission to the stroke unit.
measure: Modified Rankin Scale (mRS) after three months.
timeFrame: Three months
measure: The risk of involuntary early retirement during the follow-up period.
timeFrame: 2 - 5.5 years after admission to the stroke unit.
measure: The risk of reduced workability two years after the vascular event
timeFrame: Two years after admission to the stroke unit
measure: The percentage of time on social transfer payments during the first two years.
timeFrame: Two years after admission to the stroke unit
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
name: Kamilia S. Funder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
name: Jacob Steinmetz, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Wahlgren N, Ahmed N, Davalos A, Hacke W, Millan M, Muir K, Roine RO, Toni D, Lees KR; SITS investigators. Thrombolysis with alteplase 3-4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study. Lancet. 2008 Oct 11;372(9646):1303-9. doi: 10.1016/S0140-6736(08)61339-2. Epub 2008 Sep 12.
citation: Hesselfeldt R, Gyllenborg J, Steinmetz J, Do HQ, Hejselbaek J, Rasmussen LS. Is air transport of stroke patients faster than ground transport? A prospective controlled observational study. Emerg Med J. 2014 Apr;31(4):268-72. doi: 10.1136/emermed-2012-202270. Epub 2013 Feb 6.
citation: Funder KS, Rasmussen LS, Lohse N, Hesselfeldt R, Siersma V, Gyllenborg J, Wulffeld S, Hendriksen OM, Lippert FK, Steinmetz J. The impact of a physician-staffed helicopter on outcome in patients admitted to a stroke unit: a prospective observational study. Scand J Trauma Resusc Emerg Med. 2017 Feb 23;25(1):18. doi: 10.1186/s13049-017-0363-3.