Clinical trial NCT04834284: HEMS for Mechanical Thrombectomy
Official title: Decreasing Prehospital Delay to Mechanical Thrombectomy Using a Helicopter Emergency Medical Services Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Either verified large vessel occlusion with computed tomography angiography in Seinäjoki central hospital or positive prehospital stroke severity scale for large vessel occlusion (Finnish Prehospital Stroke Scale: FPSS) and eligibility for mechanical thrombectomy

Brief summary: Elapsed time from the onset of stroke symptoms to the point of revascularization is the key determinant of the optimal outcome of acute ischemic stroke. Pharmacological treatment is less effective if the thrombus occluding the artery is big enough and mechanical thrombectomy is required to gain recanalization. Mechanical thrombectomy can be done only in comprehensive stroke centres. There are 5 comprehensive stroke centres in Finland which causes regional inequality when it comes to reaching mechanical thrombectomy in a reasonable time limit.

The aims of the study is to measure the effect of dispatching a helicopter emergency medical services unit on the treatment delays of a stroke patient with large vessel occlusion. The HEMS unit is dispatched to both: getting patient directly to the comprehensive stroke centre as well as to interfacility tranfers.


Eligibility criteria: Inclusion Criteria:

- all adult patients transferred for mechanical thrombectomy from the South Ostrobothnia Hospital District to the Tampere University Hospital

Exclusion Criteria:

* The neurologist on call at the Tampere University hospital deems the patient unable to benefit from mechanical thrombectomy

Primary outcomes:
measure: The difference of transport times from the onset of ambulance transport to Tampere university hospital until the recording of CT Scout image
timeFrame: from onset of symptoms up to 24 hours
Secondary outcomes:
measure: The difference of onset to revascularisation time between the groups from the onset of symptoms (last known well) until save time of "post revascularization" image
timeFrame: from onset of symptoms up to 24 hours
measure: The time difference from the onset of symptoms (last known well) until the save time of "post revascularization" image
timeFrame: from onset of symptoms up to 24 hours
measure: 90 days modified Rankin scale outcome
timeFrame: telephone interview 90 days after mechanical thrombectomy
measure: Availability of the ambulance to the next emergency medical services mission in its own region. Time to next ems mission
timeFrame: from the beginning of ambulance transport up to 24 hours
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University hospital
Study officials:
affiliation: Centre of Emergency Medical Services, Tampere University Hospital
name: Sanna Hoppu, MD, PhD
role: STUDY_DIRECTOR
References: