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Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage

NCT05664191 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-08

No results posted yet for this study

Summary

Sub-arachnoid haemorrhage (SAH) are often due to ruptured intracerebral aneurysms and are associated with an importante morbi-mortality. SAH are often complicated by delayed cerebral ischemia (DCI) potentially due to cerebral vasospasm (CVS). A recent study showed that levosimendan, an inotropic and vasodilatory drug, could reduce the incidence of CVS and potentially improve patient outcome.

In this pilot randomized controlled trial, we will evaluate the impact Levosimendan vs Placebo in SAH patient on the occurrence of CVS and DCI.

Study population: adult patient admitted to ICU for aneurysmal SAH WFNS grade I-IV and mFisher 3-4.

Intervention: Levosimendan (0.1 µg/kg/min) or placebo infusion at Day 1 and 8.

Primary outcome: incidence of DCI or CVS at day 14

Duration of the study: 24 months

Number of patients: 30 (15 patients per group) Number of center: 1

Conditions

  • Sub-arachnoid Haemorrhage

Interventions

DRUG

Levosimendan

Infusion at 0.1 µg/kg/min at day 1 and day 8

OTHER

Placebo

Glucose 5%, solution for injection ECOFLAC at day 1 and day 8

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Benjamin Glen Chousterman · Hôpital Lariboisière

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2026-04-13
Completion
2026-04-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664191 on ClinicalTrials.gov