HEMS for Mechanical Thrombectomy

Decreasing Prehospital Delay to Mechanical Thrombectomy Using a Helicopter Emergency Medical Services Unit

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Pauli Vuorinen, MD; Phone Number: +358+3+311611; Email: pauli.e.vuorinen@pshp.fi

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Recruiting
    • Tampere University Hospital
    • Sub-Investigator: Piritta Setälä, MD, PhD
    • Principal Investigator: Pauli Vuorinen, MD
    • Sub-Investigator: Jyrki Ollikainen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Helicopter Emergency Medical Services (HEMS); Patients transported to the comprehensive stroke centre at least in some part by a HEMS unit
Ground Emergency Medical Services (GEMS); Patients transported to the comprehensive stroke centre solely by an ambulance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of transport times from the onset of ambulance transport to Tampere university hospital until the recording of CT Scout image	minutes	from onset of symptoms up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	minutes	from onset of symptoms up to 24 hours
The time difference from the onset of symptoms (last known well) until the save time of "post revascularization" image	minutes	from onset of symptoms up to 24 hours
90 days modified Rankin scale outcome	mRS 0-6	telephone interview 90 days after mechanical thrombectomy
Availability of the ambulance to the next emergency medical services mission in its own region. Time to next ems mission	hours	from the beginning of ambulance transport up to 24 hours

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Investigators: Study Director: Sanna Hoppu, MD, PhD, Centre of Emergency Medical Services, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: R20082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No