Actively Recruiting
Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-08
30
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
O
Orion Corporation, Orion Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 75 years
- Hospitalized in surgical intensive care at Lariboisi�e8re Hospital for aneurysmal subarachnoid hemorrhage
- WFNS clinical score between I and IV
- mFisher score of 3 or 4
You will not qualify if you...
- Pregnant women
- Known hypersensitivity to levosimendan or contraindications such as severe hypotension (mean arterial pressure < 65 mmHg), tachycardia (heart rate > 120 bpm), or cardiac mechanical obstructions
- Severe renal failure with creatinine clearance below 30 ml/min
- Severe hepatic failure with signs of hepatic encephalopathy or chronic liver disease
- History of torsades de pointes
- Pre-existing severe neurovascular pathologies
- Moribund patients
- Patients not affiliated with social security
- Participation in another interventional research study
- Patients under legal guardianship or curatorship
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Lariboisière, Service d'anesthésie Réanimation
Paris, France, France, 75010
Actively Recruiting
Research Team
B
Benjamin Glen Chousterman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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