Clinical trial NCT04121013: PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship
Official title: PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship, a Randomized Control Study in France (PRESTO-F)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: thrombectomy
drip'n'ship versus mothership
cost/effectiveness
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incremental cost-utility ratio
timeFrame: 12 months
Secondary outcomes:
measure: modified Rankin scale score
timeFrame: 90 days
Other outcomes:
measure: EuroQoL5D scale
timeFrame: 90 days
Locations:
city: Caen
country: France
facility: University hospital of Caen
state: Normanide
Study officials:
affiliation: University hospital of Caen
name: Emmanuel Touze, Pr
role: PRINCIPAL_INVESTIGATOR
References: