Informations générales (source: ClinicalTrials.gov)
Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage (MIVAR)
Interventional
Phase 3
University Hospital, Angers (Voir sur ClinicalTrials)
août 2020
mai 2026
03 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Pierre Trouiller | 21/06/2024 13:34:04 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP Lariboisière - Paris - France | Benjamin CHOUSTERMAN | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | LASOCKI, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU Besançon - Besançon - France | Laurent CARTERON | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Bordeaux - France | Matthieu BIAIS | Contact (sur clinicalTrials) | |||
| CHU Brest - Brest - France | Marie GESLAIN | Contact (sur clinicalTrials) | |||
| CHU Caen - Caen - France | Clément GAKUBA | Contact (sur clinicalTrials) | |||
| CHU Dijon - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU Lille - Lille - France | Pierre BOUSSEMART | Contact (sur clinicalTrials) | |||
| CHU Nantes - Nantes - France | Karim Lakhal, MD | Contact (sur clinicalTrials) | |||
| CHU Rennes - Rennes - France | Yoann Launey, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU Tours - Tours - France | Marc LAFFON | Contact (sur clinicalTrials) | |||
| Hôpital Civils de Lyon - Lyon - France | Baptiste BALANCA | Contact (sur clinicalTrials) | |||
| Hôpital de Hautepierre - 67098 - Strasbourg - France | Julien Pottecher, MD, PhD | Contact (sur clinicalTrials) | |||
| Hôpital Gabriel Montpied - Clermont-Ferrand - France | Russel Chabanne, MD | Contact (sur clinicalTrials) | |||
| Hôpital Gui de Chauliac - Montpellier - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Adult patients hospitalized for aneurysmal SAH
- First episode of vasospasm, with a diagnosis confirmed on cerebral arterial
CT-scanner
- Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤6 hours
- Adult patients hospitalized for aneurysmal SAH
- First episode of vasospasm, with a diagnosis confirmed on cerebral arterial
CT-scanner
- Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤6 hours
- Initial Glasgow score at 3 with a bilateral mydriasis
- Moribund patient
- Pregnant woman
- Contraindication to Milrinone (obstructive cardiomyopathy...)
- Cerebral infarction in the vasospasm area already present on the CT-scanner at the
time of diagnosis (lack of expected benefit of treatment in this case- according to
medical judgement)
- Non-affiliation to French health care coverage,
- Adult patient protected under the law (guardianship)
- Cardiac failure necessitating inotropic agents
- Uncontrolled Intracranial hypertension (ICP>25 mmHg for more than 20 min)
- Inclusion in an interventional study using Milrinone, or evaluating a treatment of
cerebral vasospasm or with the same primary endpoint (mRS at 3 months).