StrokePRESTO-FNCT04121013
PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship
A study testing mothership in people with Stroke, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- mothership
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
emmanuel touze, Pr contact
France1 site, 1 recruiting
- Recruiting
University hospital of Caen
Caen, Normanide, 14000
Richard Macrez, Dr, 0231470213, macrez@cyceron.fr
Emmanuel Touze, Pr, emmanuel.touze@unicaen.fr
About this study
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)
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- mothership
- Keywords
- thrombectomy, drip'n'ship versus mothership, cost/effectiveness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mothershipOther
Randomized controlled study: allocation to active or no intervention arm will be done accordingly to the design temporal sequence
| Study group | Role | What they receive |
|---|---|---|
| Mothership | Active comparator | Acute stroke patients with suspected large vessel occlusion will be directly transferred to the nearest transportation to the endovascular center Receives: Other: mothership |
| drip'n'ship | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start30 Jan 2021
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Touze, Pr, Principal investigator, University hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121013
- Sponsor's protocol ID
- 2018-A02873-52
- Acronym
- PRESTO-F
- Status last verified
- Apr 2021
- First submitted
- 2 Oct 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04121013
- Acronym / sponsor ID
- PRESTO-F / 2018-A02873-52
- Conditions
- Stroke
- Keywords
- thrombectomy, drip'n'ship versus mothership, cost/effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothership | Active comparator | Other: mothershipAcute stroke patients with suspected large vessel occlusion will be directly transferred to the nearest transportation to the endovascular center |
| drip'n'ship | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mothershipRandomized controlled study: allocation to active or no intervention arm will be done accordingly to the design temporal sequence | Other | Mothership |
Primary outcome
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).
1 secondary outcome
modified Rankin scale score
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emmanuel touze, Pr contact
Emmanuel Touze, Pr principal investigator
University hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mothership in people with Stroke, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Macrez, Dr (0231470213, macrez@cyceron.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost-utility ratio (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.