Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion
- Conditions
- Stroke
- Registration Number
- NCT02795962
- Lead Sponsor
- Fundacio Ictus Malaltia Vascular
- Brief Summary
To evaluate the hypothesis that direct transfer to an Endovascular Stroke Center, compared to transfer to the closest Local Stroke Center, offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with clinically suspected Large Vessel Occlusion identified by Emergency Medical Services (EMS).
- Detailed Description
Prospective, multicenter, cluster randomized controlled, usual care conditions, open, blinded-endpoint trial of acute stroke patients with suspected acute large vessel occlusion (LVO) identified by EMS at first assistance on the field, in which two strategies will be compared: transfer to the closest local stroke center (Local-SC) Vs. direct transfer to an endovascular stroke center (EVT-SC).
The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Upon candidate identification, EMS will contact a stroke neurologist on call using a prehospital telestroke system who will confirm inclusion criteria and will allocate the subjects to a specific intervention according to a pre-established temporal sequence. Allocation will account for 3 strata: time band (two groups of 12 hours), territory (metropolitan versus provincial area) and week day (working versus weekend day).
Subjects will be followed up to 90 days post-randomization.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1401
- Suspected LVO acute stroke patients identified by a RACE scale score >4 at the pre-hospital setting, that is evaluated by EMS professionals when attending patients, in non-stroke ready centers or primary health centers, previous to the transfer to a stroke center.
- Patients located in geographical areas in which the reference stroke center is a hospital not capable to offer endovascular treatment (Primary stroke Center or Telestroke Center).
- Estimated arrival time at an EVT-SC <7 hours from symptom onset. Symptom onset is defined as point in time the patient was last seen well (at baseline).
- No significant pre-stroke functional disability (modified Rankin scale 0 - 2)
- Age ≥18
- Deferred informed consent obtained from patient or acceptable patient surrogate (after the acute phase, as permission to use clinical data within a clinical registry)
- Patients in a coma (NIHSS item of consciousness >1)
- Patients with unstable clinical status who require emergent life support care
- Serious, advanced, or terminal illness with anticipated life expectancy of less than 6 month.
- Suspected LVO acute stroke patients identified at the Emergency Department of a stroke center
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
- Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method modified Rankin Scale score (shift analysis) 90 days Modified Rankin Scale score in ischemic stroke patients as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment.
- Secondary Outcome Measures
Name Time Method Mortality in all patients 90 days Mortality in all patients included
Mortality in hemorrhagic stroke patients 90 days Mortality in hemorrhagic stroke patients
Clinical deterioration requiring orotracheal intubation during transfers 8 hours Orotracheal intubation during transfers
Clinical deterioration 24 hours Clinical deterioration (≥4 points on the NIHSS)
Reperfusion therapies 8 hours Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset
Time from symptom onset to reperfusion therapies 8 hours Time from symptom onset to iv tPA administration (for patients treated with iv tPA) and to groin puncture (for patients treated with endovascular).
Subgroup analysis 90 days Distribution of the modified Rankin Scale score at 90 days (shift analysis) in the following subgroups:
* Ischemic / hemorrhagic
* Patients eligible for iv t-PA vs. non iv t-PA eligible when attended by EMS (within time window considering transfer time to the nearest SC, no formal contraindications as recent major surgery or anticoagulation)
* Patients treated with EVTClinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center 90 days To analyze whether an inflection point exists with respect to time from onset to arrival at the Endovascular Center beyond which transfer to a Local-SC is beneficial or equivalent.
Dramatic early favorable response 24 (-2/+12 hours) Dramatic early favorable response as determined by an NIHSS (National Institute of Health Stroke Scale) of 0-2 or NIHSS improvement ≥ 8 points in ischemic stroke and hemorrhagic stroke patients.
Trial Locations
- Locations (12)
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Bellvitge
🇪🇸Barcelona, Spain
Hospital Clínic
🇪🇸Barcelona, Spain
Hospital Mar
🇪🇸Barcelona, Spain
Hospital Moisés Broggi
🇪🇸Barcelona, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Josep Trueta
🇪🇸Girona, Spain
Hospital Arnau Vilanova
🇪🇸Lleida, Spain
Hospital Althaia
🇪🇸Manresa, Spain
Scroll for more (2 remaining)Hospital Germans Trias i Pujol🇪🇸Badalona, Spain