HeadSOAR, a Multicenter, Randomized, Open-Label Trial of Head Positioning After Endovascular Therapy for Large Vessel Occlusion Stroke: Study Rationale and Design

BackgroundThe elevated head position may lower intracranial pressure but has been associated with an increased risk of early neurological deterioration before endovascular therapy (EVT). However, among patients with medium-to-large infarct cores who achieve successful reperfusion after EVT, the efficacy and safety of elevated head positioning remain uncertain. ObjectiveThis study aims to evaluate whether maintaining patients in an elevated head position (30{degrees}-40{degrees}) versus a flat lying position (0{degrees}-10{degrees}) for 72 hours after EVT improves functional outcomes at 90 days. Methods and designThe Head Positioning After Endovascular Therapy for Acute Ischemic Stroke (HeadSOAR) trial is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded-end point (PROBE) trial. A total of 1,332 patients with acute anterior circulation LVO, medium to large core strokes, successful reperfusion (eTICI [≥]2b) after EVT, will be randomized in a 1:1 ratio to either an elevated head position (30{degrees}-40{degrees}) or flat lying position (0{degrees}-10{degrees}) for 72 hours. OutcomesThe primary outcome is the distribution of modified Rankin Scale (mRS) scores at 90 days. Secondary outcomes include the proportions of patients with mRS scores of 0-1, 0-2, and 0-3, as well as the European Quality Visual Analogue Scale (EQ-VAS) score at 90 days. Safety endpoints include 90-day mortality and adverse events. The study will be conducted in more than 60 centers in China, with a planned completion in 2025. ConclusionThe HeadSOAR trial will provide evidence on whether elevated head positioning after EVT influences functional recovery. Trial registry numberNCT06115707 (www.clinicaltrials.gov).