PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship (PRESTO-F)

April 9, 2021 updated by: University Hospital, Caen

PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship, a Randomized Control Study in France (PRESTO-F)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mothership
Acute stroke patients with suspected large vessel occlusion will be directly transferred to the nearest transportation to the endovascular center
Other: mothership
Randomized controlled study: allocation to active or no intervention arm will be done accordingly to the design temporal sequence
NO_INTERVENTION: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental cost-utility ratio
Time Frame: 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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin scale score
Time Frame: 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
90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQoL5D scale
Time Frame: 90 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Emmanuel Touze, Pr, University Hospital of Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (ACTUAL)

October 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02873-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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