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

8 juli 2016 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Trombolys

Studietyp

Observationell

Inskrivning (Faktisk)

1068

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Barn
Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: Kohort
Tidsperspektiv: Blivande

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Risk of death during follow-up Tidsram: 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.

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
The risk of death at 30 day. Tidsram: 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. Tidsram: Three months	Assessed in patients who underwent thrombolysis.	Three months
The risk of involuntary early retirement during the follow-up period. Tidsram: 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 Tidsram: 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. Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Rigshospitalet, Denmark

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2010

Primärt slutförande (Faktisk)

1 maj 2015

Avslutad studie (Faktisk)

1 maj 2015

Studieregistreringsdatum

Först inskickad

13 oktober 2015

Först inskickad som uppfyllde QC-kriterierna

13 oktober 2015

Första postat (Uppskatta)

15 oktober 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 juli 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 juli 2016

Senast verifierad

1 juli 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

ALH3-KF-2015

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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