Using Levosimendan to treat complications from aneurysmal subarachnoid hemorrhage
Use of Levosimendan as Treatment of Aneurysmal SubArachnoid Hemorrhage
PHASE2 · Assistance Publique - Hôpitaux de Paris · NCT05664191
This study is testing if the drug levosimendan can help adults with aneurysmal subarachnoid hemorrhage by reducing complications like cerebral vasospasm and delayed cerebral ischemia.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, France) |
| Trial ID | NCT05664191 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial aims to evaluate the effectiveness of levosimendan, an inotropic and vasodilatory drug, in reducing the incidence of cerebral vasospasm (CVS) and delayed cerebral ischemia (DCI) in adult patients with aneurysmal subarachnoid hemorrhage (SAH). Patients will be randomly assigned to receive either levosimendan or a placebo infusion on days 1 and 8 of their treatment. The primary outcome will be assessed at day 14, focusing on the occurrence of CVS and DCI. The study will take place at a single center over a duration of 24 months, involving a total of 30 patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are hospitalized for aneurysmal SAH with a WFNS clinical score of I to IV and a mFisher score of 3 or 4.
Not a fit: Patients with severe renal or hepatic failure, contraindications to levosimendan, or those who are moribund will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from complications related to aneurysmal subarachnoid hemorrhage.
How similar studies have performed: Previous studies have shown promising results with levosimendan in similar contexts, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, France
- Hôpital Lariboisière, Service d'anesthésie Réanimation — Paris, France, France (RECRUITING)
Study contacts
- Study coordinator: Benjamin Glen Chousterman
- Email: Benjamin.chousterman@aphp.fr
- Phone: 01.49.95.85.15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sub-arachnoid Haemorrhage, Sub-arachnoid haemorrhage, vasospasm, delayed cerebral ischemia, stroke