Stroke
Conditions
Keywords
Endovascular Procedures, Emergency Medical Services
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.
Interventions
OTHERDirect transfer to an Endovascular Center
Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence
Sponsors
Medtronic
Anagram-ESIC
UPC
BioClever 2005 S.L.
Fundacio Ictus Malaltia Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Mortality in all patients | 90 days | Mortality in all patients included |
| 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 EVT |
| Clinical 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. |
| 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). |
Countries
Spain
Outcome results
None listed