drugset / Trial / NCT04282629

Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

NCT04282629

Phase 2 Recruiting 234 enrolled University Hospital, Toulouse
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.

Timeline

Start
2021-07-25
Primary completion
2025-07
Completion
2025-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Milrinone Small molecule 0.75 ug/kg Intravenous