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

8 juli 2016 bijgewerkt door: Kamilia S. Funder, Rigshospitalet, Denmark

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).

Studie Overzicht

Toestand

Voltooid

Conditie

Trombolyse

Studietype

Observationeel

Inschrijving (Werkelijk)

1068

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Cohort
Tijdsperspectieven: Prospectief

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Risk of death during follow-up Tijdsspanne: 2 - 5.5 years after admission to the stroke unit.	Mortality during the follow-up period will be analysed for differences between GEMS and HEMS. Follow-up period is until May 1st 2015. Because of varying access to information on covariates depending on the diagnosis and treatment of the patient, we conduct the analysis as follows: 1) the whole study population; adjusted for sex and age, 2) patients who were suspected of suffering from a vascular condition; adjusted for sex, age and comorbidity (defined as one of the following conditions; diabetes, atrial fibrillation, hypertension, previous myocardial infarction, and previous stroke), and 3) patients who underwent thrombolysis; adjustment for sex, age, comorbidity, and initial National Institutes of Health Stroke Scale (NIHSS) score.	2 - 5.5 years after admission to the stroke unit.

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
The risk of death at 30 day. Tijdsspanne: 30 days after admission to the stroke unit.	Patients are divided into the same three sub-groups and adjusted for the same potential confounders as described in the primary outcome analysis.	30 days after admission to the stroke unit.
Modified Rankin Scale (mRS) after three months. Tijdsspanne: Three months	Assessed in patients who underwent thrombolysis.	Three months
The risk of involuntary early retirement during the follow-up period. Tijdsspanne: 2 - 5.5 years after admission to the stroke unit.	Assessed in all patients suspected of suffering from a vascular condition between 18 and 60 years of age to ensure a sample that was at risk of involuntary early retirement during the full follow-up period.	2 - 5.5 years after admission to the stroke unit.
The risk of reduced workability two years after the vascular event Tijdsspanne: Two years after admission to the stroke unit	Assessed in all patients suspected of suffering from a vascular condition between 18 and 60 years of age to ensure a sample that was at risk of involuntary early retirement during the full follow-up period.	Two years after admission to the stroke unit
The percentage of time on social transfer payments during the first two years. Tijdsspanne: Two years after admission to the stroke unit	Assessed in all patients suspected of suffering from a vascular condition between 18 and 60 years of age to ensure a sample that was at risk of involuntary early retirement during the full follow-up period.	Two years after admission to the stroke unit

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rigshospitalet, Denmark

Onderzoekers

Hoofdonderzoeker: Kamilia S. Funder, MD, Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Studie directeur: Jacob Steinmetz, MD, PhD, Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2010

Primaire voltooiing (Werkelijk)

1 mei 2015

Studie voltooiing (Werkelijk)

1 mei 2015

Studieregistratiedata

Eerst ingediend

13 oktober 2015

Eerst ingediend dat voldeed aan de QC-criteria

13 oktober 2015

Eerst geplaatst (Schatting)

15 oktober 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

11 juli 2016

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2016

Laatst geverifieerd

1 juli 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

ALH3-KF-2015

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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