HEMS for Mechanical Thrombectomy

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04834284
• Other study ID #: R20082
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Tampere University Hospital
• Contact: Pauli Vuorinen, MD
• Phone: +358+3+311611
• Email: pauli.e.vuorinen[@]pshp.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke

Locations

Country	Name	City	State
Finland	Tampere University hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	90 days modified Rankin scale outcome	mRS 0-6	telephone interview 90 days after mechanical thrombectomy
Secondary	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