Clinical Trial

Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Study acronym: OPTIMIL
Recruiting Phase 2
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Record status
This record was last updated September 25, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-02-20; most recent amendment 2024-09-23.
Status change: Not Yet Recruiting → Recruiting 2021-08-23
Trial Details
NCT Number NCT04282629
Lead Sponsor University Hospital, Toulouse
Conditions Aneurysmal Subarachnoid Hemorrhage
Enrollment 234 participants
Start Date 2021-07-25
Primary Completion 2025-07 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2024-09-25