Use of Levosimendan as Treatment of Aneurysmal SubArachnoid Hemorrhage

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Lariboisière, Service d'anesthésie Réanimation
RECRUITING
Paris
Contact Information
Primary
Benjamin Glen Chousterman
Benjamin.chousterman@aphp.fr
01.49.95.85.15
Time Frame
Start Date: 2023-10-13
Estimated Completion Date: 2026-04-13
Participants
Target number of participants: 30
Treatments
Experimental: LEVOSIMENDAN
Experimental : Levosimendan group
Placebo_comparator: PLACEBO
Placebo : Comparator group
Related Therapeutic Areas
Sponsors
Collaborators: Orion Corporation, Orion Pharma
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov