Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial

Abstract

Background Optimal blood pressure is not well established during endovascular therapy of acute ischemic stroke. Applying standardized blood pressure target values for every stroke patient might be a suboptimal approach. Aim To assess whether an individualized intraprocedural blood pressure management with individualized blood pressure target ranges might pose a better strategy for the outcome of the patients than standardized blood pressure targets. Sample size: Randomization of 250 patients 1:1 to receive either standard or individualized blood pressure management approach. Methods and design We conduct an explorative single-center randomized controlled trial with a PROBE (parallel-group, open-label randomized controlled trial with blinded endpoint evaluation) design. In the control group, intraprocedural systolic blood pressure target range is 140–180 mmHg. The intervention group is the individualized approach, which is maintaining the intraprocedural systolic blood pressure at the level on presentation (±10 mmHg). Study outcomes: The primary endpoint is the modified Rankin scale assessed 90 days +/− 2 weeks after stroke onset, dichotomized by 0–2 (favorable outcome) to 3–6 (unfavorable outcome). Secondary endpoints include early neurological improvement, infarction size, and systemic physiology monitor parameters. Discussion An individualized approach for blood pressure management during thrombectomy could lead to a better outcome for stroke patients. The trial is registered at clinicaltrials.gov as ‘Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)’ under NCT04578288.