NCT04121013

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

October 2, 2019

Last Update Submit

April 9, 2021

Conditions

Stroke

Keywords

thrombectomydrip'n'ship versus mothershipcost/effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • modified Rankin scale score

    90 days

Other Outcomes (1)

  • EuroQoL5D scale

    90 days

Study Arms (2)

Mothership

ACTIVE COMPARATOR

Acute stroke patients with suspected large vessel occlusion will be directly transferred to the nearest transportation to the endovascular center

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

Interventions

mothershipOTHER

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

Mothership

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Caen

Caen, Normanide, 14000, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Emmanuel Touze, Pr

    University hospital of Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Macrez, Dr

CONTACT

0231470213macrez@cyceron.fr

emmanuel touze, Pr

CONTACT

emmanuel.touze@unicaen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 9, 2019

Study Start

January 30, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)