Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

Who is this study for? Adult patients with subarachnoid hemorrhage
What treatments are being studied? Milrinone
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality. Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months. This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).

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

• Adult patients hospitalized for aneurysmal SAH

• First episode of vasospasm, with a diagnosis confirmed on cerebral arterial CT-scanner

• Delay between diagnosis of vasospasm (done by CT-scanner) and inclusion ≤6 hours

• Informed consent from a legal representative, or emergency procedure

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Besançon
RECRUITING
Besançon
CHU Bordeaux
RECRUITING
Bordeaux
CHU Brest
RECRUITING
Brest
CHU Caen
RECRUITING
Caen
Hôpital Gabriel Montpied
RECRUITING
Clermont-ferrand
CHU Dijon
TERMINATED
Dijon
CHU Lille
RECRUITING
Lille
Hôpital Civils de Lyon
RECRUITING
Lyon
Hôpital Gui de Chauliac
TERMINATED
Montpellier
CHU Nantes
RECRUITING
Nantes
APHP Lariboisière
RECRUITING
Paris
Hôpital Fondation ROTHSCHILD
RECRUITING
Paris
CHU Rennes
RECRUITING
Rennes
Hôpital de Hautepierre
RECRUITING
Strasbourg
CHU Tours
RECRUITING
Tours
Contact Information
Primary
Sigismond SL LASOCKI, PU-PH
silasocki@chu-angers.fr
02 41 35 36 35
Time Frame
Start Date: 2020-08-10
Estimated Completion Date: 2026-01-11
Participants
Target number of participants: 370
Treatments
Experimental: Milrinone
The patients randomized to this arm will have Milrinone (Laboratoires STRAGEN, France)
Placebo_comparator: Placebo
The patients randomized to this arm will have Saline solution
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Angers

This content was sourced from clinicaltrials.gov