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Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
Sponsor: University Hospital, Toulouse
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.
Official title: Efficacy of 10 Days Intravenous Milrinone Treatment to Optimize Cerebral Hemodynamic and Prevent Delayed Cerebral Ischemia (DCI) in Patients with Severe Subarachnoid Hemorrhage Due to Intracranial Aneurysm Rupture
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2021-07-25
Completion Date
2025-07
Last Updated
2024-09-25
Healthy Volunteers
No
Conditions
Interventions
Milrinone Injection
administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14
Placebo
administration of placebo (intravenous glucose 5%) from Day 4 to Day 14
Locations (5)
University Hospital Bordeaux
Bordeaux, France
CHUGA
Grenoble, France
University Hospital of La Réunion
La Réunion, France
HCL
Lyon, France
University Hospital of Toulouse
Toulouse, France