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

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).

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Key information

Conditions

Thrombolysis

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Risk of death during follow-up

Time frame: 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.

Secondary outcomes

The risk of death at 30 day.

Time frame: 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.
Modified Rankin Scale (mRS) after three months.

Time frame: Three months

Assessed in patients who underwent thrombolysis.
The risk of involuntary early retirement during the follow-up period.

Time frame: 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.
The risk of reduced workability two years after the vascular event

Time frame: 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.
The percentage of time on social transfer payments during the first two years.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Oct 15, 2015
Registry last updated: Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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