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RECRUITING
NCT04282629
PHASE2

Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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

Interventions

DRUG

Milrinone Injection

administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14

OTHER

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