Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage (NCT05664191) | Clinical Trial Compass
RecruitingPhase 2
Levosimendan as Treatment of Aneurysmal SubArachnoid Haemorrhage
France30 participantsStarted 2023-10-13
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* pregnant women
* 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 renal failure (creatinine clearance \< 30 ml/min)
* severe hepatic failure (signs of hepatic encephalopathy) or chronic liver disease
* history of torsades de pointes
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.