PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship
NCT ID: NCT04121013
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
800 participants
INTERVENTIONAL
2021-01-30
2022-01-31
Brief Summary
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Objective: To compare cost/effectiveness of transfer to the closest local stroke centre or telemedicine hub to direct transfer to the comprehensive stroke cent(CSC) in patients acute stroke with suspected large vessel occlusion.
Medical and economic expected impact: We hypothesize that direct transportation to CSC is associated with better clinical outcome in case of acute ischaemic stroke due to intracranial large vessel occlusion. However, we have to demonstrate that this approach is not associated with time from onset harm in patients not eligible to mechanical thrombectomy.
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Detailed Description
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Primary endpoint: Incremental cost-utility ratio at 12 months. Secondary endpoints: modified Rankin scale and EuroQoL5D scale at 3 months.
Eligibility criteria: A call to the emergency medical assistance service, 18 years and older, severe acute stroke symptoms, transportation time from scene to the CSC longer than time to go to the nearest stroke unit or telemedicine hub, transportation time from scene to the CSC compatible with IV thrombolysis, known time from onset, RACE score (assessed by medical emergency technicians) ≥5.
Experimental arm: direct transportation to the CSC. Control arm: transfer to the closest local stroke centre or telemedicine hub.
Sample size: 800 patients, 400 for each arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Mothership
Acute stroke patients with suspected large vessel occlusion will be directly transferred to the nearest transportation to the endovascular center
mothership
Randomized controlled study: allocation to active or no intervention arm will be done accordingly to the design temporal sequence
drip'n'ship
Acute stroke patients with suspected large vessel occlusion will be transferred to the closest local stroke centre or telemedicine hub as done with the current stroke protocol
No interventions assigned to this group
Interventions
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mothership
Randomized controlled study: allocation to active or no intervention arm will be done accordingly to the design temporal sequence
Eligibility Criteria
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Inclusion Criteria
* age\> 18y,
* known time of stroke onset;
* transportation time from scene to the CSC longer than time to go to the nearest stroke unit or telemedicine hub;
* transportation time from scene to the CSC compatible with IV thrombolysis;
* known time from onset, RACE score ≥5.
Exclusion Criteria
* no ambulance available
* bedridden patient
18 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Principal Investigators
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Emmanuel Touze, Pr
Role: PRINCIPAL_INVESTIGATOR
University hospital of Caen
Locations
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University hospital of Caen
Caen, Normanide, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-A02873-52
Identifier Type: -
Identifier Source: org_study_id
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