PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship

Not Applicable

• Conditions: Stroke
• Interventions: Other: mothership

• Registration Number: NCT04121013
• Lead Sponsor: University Hospital, Caen

Brief Summary

Background: The outcome of ischemic stroke is related to the brain lesion volume and this volume of infarction is directly related to the time to reperfusion, which therefore depends on the time to initiation of therapy. Acute ischemic stroke is treated medically with the administration of intravenous rtPA, but recent randomized controlled trials have shown the efficacy of mechanical thrombectomy and is now the new gold standard in ischemic stroke. This new therapeutic strategy has created two possibilities for pre-hospital decision-making: i/ transport the patient directly to the nearest stroke unit to receive alteplase and then if indicated perform a thrombectomy (drip and ship) or ii/ bypassing thrombolysis centres in favour of endovascular thrombectomy (mothership).

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.

Detailed Description

Design: Multicenter, two-arm, prospective, open, blinded end-point (PROBE), randomized, clinical trial

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.

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2021-01-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-14
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• A call to the emergency medical assistance service;
• 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

• transportation time from scene to the CSC longer than time to go to the nearest stroke unit or telemedicine hub.
• no ambulance available
• bedridden patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mothership	mothership	Acute stroke patients with suspected large vessel occlusion will be directly transferred to the nearest transportation to the endovascular center

Primary Outcome Measures

Name	Time	Method
Incremental cost-utility ratio	12 months	Incremental cost-utility ratio (ICUR) at 12 months, defined as the ratio of the incremental cost of management by transfer to a CSC with MT (compared to the control arm "local PSC") to the gain in healthy survival (quality adjusted life years, QALYs).

Secondary Outcome Measures

Name	Time	Method
modified Rankin scale score	90 days	is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. Modified Rankin Scale score will be evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment

Trial Locations

Locations (1)

University hospital of Caen; 🇫🇷 Caen, Normanide, France