HEMS for Mechanical Thrombectomy

NCT04834284 | Unknown

• 1 other identifier: R20082
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  from onset of symptoms up to 24 hours

• 90 days modified Rankin scale outcome

  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

  from the beginning of ambulance transport up to 24 hours

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University hospital

Tampere, 33521, Finland

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sanna Hoppu, MD, PhD

  Centre of Emergency Medical Services, Tampere University Hospital

  STUDY DIRECTOR

Central Study Contacts

Pauli Vuorinen, MD

CONTACT

+358+3+311611; pauli.e.vuorinen@pshp.fi

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of Emergency Medical Services

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 8, 2021
• Study Start: June 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

FI (1)