The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients

NCT ID: NCT02576379

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1068 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Thrombolysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HEMS patients

Patients suspected of suffering from a vascular condition within the geographical area covered by both HEMS and GEMS, and were transported by Helicopter Emergency Medical System (HEMS) to the regional stroke unit at Copenhagen University Hospital Roskilde in a 36-month period from May 1st 2010 until April 30th 2013.

No interventions assigned to this group

GEMS patients

Patients suspected of suffering from a vascular condition within the geographical area covered by both HEMS and GEMS, and were transported by Ground Emergency Medical System (GEMS) to the regional stroke unit at Copenhagen University Hospital Roskilde in a 40-month period from January 1st 2010 until April 30th 2013.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kamilia S. Funder

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamilia S. Funder, MD

Role: PRINCIPAL_INVESTIGATOR

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

Jacob Steinmetz, MD, PhD

Role: STUDY_DIRECTOR

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

References

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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.

Reference Type BACKGROUND
PMID: 18790527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23389831 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28231814 (View on PubMed)

Other Identifiers

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ALH3-KF-2015

Identifier Type: -

Identifier Source: org_study_id

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