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

Thrombolysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576379
• Other study ID #: ALH3-KF-2015
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: July 8, 2016
• Start date: January 2010
• Est. completion date: May 2015

Study information

• Verified date: July 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Health and Medicines Authority
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1068
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Emergencies
• Thrombolysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

References & Publications (2)

Hesselfeldt R, Gyllenborg J, Steinmetz J, Do HQ, Hejselbæk J, Rasmussen LS. Is air transport of stroke patients faster than ground transport? A prospective controlled observational study. Emerg Med J. 2014 Apr;31(4):268-72. doi: 10.1136/emermed-2012-202270. Epub 2013 Feb 6. — View Citation

Wahlgren N, Ahmed N, Dávalos A, Hacke W, Millán M, Muir K, Roine RO, Toni D, Lees KR; SITS investigators. Thrombolysis with alteplase 3-4.5 h after acute ischaemic stroke (SITS-ISTR): an observational study. Lancet. 2008 Oct 11;372(9646):1303-9. doi: 10.1016/S0140-6736(08)61339-2. Epub 2008 Sep 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of death during follow-up	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.	No
Secondary	The risk of death at 30 day.	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.	No
Secondary	Modified Rankin Scale (mRS) after three months.	Assessed in patients who underwent thrombolysis.	Three months	No
Secondary	The risk of involuntary early retirement during the follow-up period.	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.	No
Secondary	The risk of reduced workability two years after the vascular event	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	No
Secondary	The percentage of time on social transfer payments during the first two years.	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	No