NCT02795962

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

A Trial Comparing Transfer to the Closest Local Stroke Center vs. Direct Transfer to Endovascular Stroke Center of Acute Stroke Patients With Suspected Large Vessel Occlusion in the Catalan Territory.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,401 (actual)
• Sponsor: Fundacio Ictus Malaltia Vascular · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	Direct 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

Timeline

• Start date: 2017-03-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2016-06-10
• Last updated: 2021-03-16

Locations

12 sites across 1 country: Spain