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Phase 2
Age: 18Years +
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ID04282629

Treatment Study of Intravenous Milrinone for Preventing Delayed Cerebral Ischemia in Severe Subarachnoid Hemorrhage Patients

Led by University Hospital, Toulouse · Updated on 2024-09-25

234

Participants Needed

5

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research evaluates the effect of intravenous milrinone on brain blood flow and prevention of delayed cerebral ischemia DCI in adults with severe subarachnoid hemorrhage caused by ruptured brain aneurysms. The study focuses on patients who are comatose or sedated shortly after the hemorrhage and aims to determine how 10 days of milrinone compared to placebo affects the volume of brain lesions related to DCI. This randomized, double-blind, multi-center trial addresses a major cause of death and disability where current treatments lack strong scientific evidence. Participants receive either standard care plus milrinone infusion or standard care plus a placebo infusion starting from day 4 to day 14 after aneurysm treatment. Milrinone is given intravenously at a dose of 0.75 micrograms per kilogram per minute. Both groups are closely monitored for signs of vasospasm and may receive additional endovascular treatment if needed. Daily clinical exams and collection of biological data occur during this high-risk period. The study observes complications related to intensive care such as neurological, pulmonary, cardiac, and septic events. Throughout the study, brain CT scans are done at 48 hours post-treatment and again at 1 month to measure DCI lesion volumes. Neurological outcomes, quality of life, and mortality are assessed at multiple points up to one year. Safety is monitored continuously, and detailed data on complications and time spent in intensive care are recorded. This comprehensive follow-up helps researchers evaluate the impact of milrinone on brain injury and recovery after severe subarachnoid hemorrhage.

CONDITIONS

Brief Title

Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Research Team

T

Thomas Geeraerts, MD PhD

N

Nadera AINAOUI

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