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

8 luglio 2016 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1068

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Risk of death during follow-up
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The risk of death at 30 day.
Lasso di tempo: 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.
Lasso di tempo: Three months
Assessed in patients who underwent thrombolysis.
Three months
The risk of involuntary early retirement during the follow-up period.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Kamilia S. Funder, MD, Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
  • Direttore dello studio: Jacob Steinmetz, MD, PhD, Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2010

Completamento primario (Effettivo)

1 maggio 2015

Completamento dello studio (Effettivo)

1 maggio 2015

Date di iscrizione allo studio

Primo inviato

13 ottobre 2015

Primo inviato che soddisfa i criteri di controllo qualità

13 ottobre 2015

Primo Inserito (Stima)

15 ottobre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 luglio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2016

Ultimo verificato

1 luglio 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ALH3-KF-2015

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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