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

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ClinicalTrials.gov Identifier: NCT02576379
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Kamilia S. Funder, Rigshospitalet, Denmark

Brief Summary:

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).


Condition or disease
Thrombolysis

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1068 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Impact of a Helicopter Emergency Medical System on Prognosis in Stroke Patients
Study Start Date : January 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Group/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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Modified Rankin Scale (mRS) after three months. [ Time Frame: Three months ]
    Assessed in patients who underwent thrombolysis.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576379


Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Kamilia S. Funder, MD Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Study Director: Jacob Steinmetz, MD, PhD Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
Additional Information:

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kamilia S. Funder, MD., Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02576379    
Other Study ID Numbers: ALH3-KF-2015
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by Kamilia S. Funder, Rigshospitalet, Denmark:
Helicopter Emergency Medical System
Mortality
Labour market affiliation
Modified Rankin Scale
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes