Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

Summary

Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality.

Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.

This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).

Conditions

• Vasospasm

Interventions

DRUG

Milrinone 1 Mg/mL Solution for Injection

Blinding procedure will be set up for the administration of the treatment

DRUG

Saline solution for injection

Blinding procedure will be set up for the administration of the treatment

Sponsors & Collaborators

• University Hospital, Angers

  lead OTHER_GOV

Principal Investigators

• Karim KL LAKHAL, PH · University Hospital of Nantes

• Olivier OH HUET, PU-PH · Cavale Blanche - University Hospital of Brest

• Pierre-François PP PERRIGAULT, PU-PH · Hôpital Gui de Chauliac - University Hospital of Montpellier

• Julien JP POTTECHER, PU-PH · Hôpital de Hautepierre, University Hospital of Strasbourg

• Russel RC CHABANNE, PH · Hôpital Gabriel Montpied, University Hospital of Clermont-Ferrand

• Benjamin BC Chousterman, PH · Hôpital Lariboisière, Paris (AP-HP)

• Marc ML Laffon, PU-PH · Hôpital Bretonneau - University Hospital of Tours

• Yoann YL Launey, PH · University Hospital of Rennes

• Claire CD Dahyot Fizelier, PU-PH · University Hospital of Poitiers

• Belaid BB Bouhemad, PU-PH · University Hospital of Dijon

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-10

Primary Completion

2025-10-11

Completion

2026-01-12

Countries

• France

Study Locations