Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion "RACECAT"

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Direct transfer to an Endovascular Center Other
    Intervention Desc: Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence
    ARM 1: Kind: Experimental
    Label: Transfer to an Endovascular Center
    Description: Acute stroke patients with suspected acute large vessel occlusion identified by EMS at first assistance on the field will be directly transferred to the nearest Endovascular Center bypassing the Local Stroke Center.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Health Services Research
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary modified Rankin Scale score (shift analysis) 90 days No
Secondary Mortality in all patients 90 days Yes
Secondary Mortality in hemorrhagic stroke patients 90 days Yes
Secondary Clinical deterioration requiring orotracheal intubation during transfers 8 hours Yes
Secondary Clinical deterioration 24 hours Yes
Secondary Reperfusion therapies 8 hours No
Secondary Time from symptom onset to reperfusion therapies 8 hours No
Secondary Subgroup analysis 90 days No
Secondary Clinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center 90 days No
Secondary Dramatic early favorable response 24 (-2/+12 hours) No

Sponsors