NCT05664191CompletedPhase 2
Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage
Use of Levosimendan as Treatment of Aneurysmal SubArachnoid Hemorrhage
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 28 Jul 2022
- Start date
- 13 Oct 2023
- Primary completion date
- 13 Apr 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke
- NCT number
- NCT05664191
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 13 Oct 2023 to the primary completion date, 13 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- contraindications to levosimendan (including hypersensitivity to levosimendan, severe hypotension (mean arterial pressure less than 65 mmHg), tachycardia (heart rate greater than 120 bpm), cardiac mechanical obstructions)
- severe hepatic failure (signs of hepatic encephalopathy) or chronic liver disease
- history of torsades de pointes
Lab values
- severe renal failure (creatinine clearance \< 30 ml/min)
Other
- pregnant women
- pre-existing severe neurovascular pathologies.
- Moribund patients.
- Patient not affiliated to social security
- Patient participating in another interventional research
- Patients under legal guardianship or curatorship
Who the study is looking for
- All adult patients (18 to 75 years old),
- hospitalized in surgical intensive care at Lariboisière Hospital for subarachnoid haemorrhage of aneurysmal origin
- WFNS clinical score of I to IV and a mFisher score of 3 or 4.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Lariboisière, Service d'anesthésie Réanimation Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.