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

Stroke Clinical Trial

— PRESTO-F  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121013
• Other study ID #: 2018-A02873-52
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2021
• Est. completion date: January 2022

Study information

• Verified date: April 2021
• Source: University Hospital, Caen
• Contact: Richard Macrez, Dr
• Phone: 0231470213
• Email: macrez[@]cyceron.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• mothership
Randomized controlled study: allocation to active or no intervention arm will be done accordingly to the design temporal sequence

Locations

Country	Name	City	State
France	University hospital of Caen	Caen	Normanide

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EuroQoL5D scale	EQ-5D is a standardized instrument for measuring generic health status. In the description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.; EuroQol5D scale will be evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment	90 days
Primary	Incremental cost-utility ratio	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).	12 months
Secondary	modified Rankin scale score	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	90 days