Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage (NCT04362527) | Clinical Trial Compass
CompletedPhase 3
Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage
France370 participantsStarted 2020-08-10
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 (done by CT-scanner) and inclusion ≤6 hours
* Informed consent from a legal representative, or emergency procedure
Exclusion Criteria:
* Initial Glasgow score at 3 with a bilateral mydriasis
* Moribund patient
* Contraindication to Milrinone (notably 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)
* Cardiac failure requiring inotrope administration at the time of randomisation
* Uncontrolled elevated intra-cranial pressure (i.e. ICP\>25 mmHg for more than 20 minutes)
* Patient with flutter or cardiac arrhythmia (atrial fibrillation) poorly tolerated
* Major metabolic disturbance (uncorrected hypokalaemia \<3 mmol/L)
* Non-affiliation to French health care coverage,
* Pregnant, breastfeeding or parturient woman
* Adult deprived of their liberty by judicial or administrative decision
* Adult under compulsory psychiatric care
* Adult patient protected under the law (guardianship or trusteeship)
* Inclusion in an interventional study using Milrinone, or evaluating a treatment of cerebral vasospasm or with the same primary endpoint (mRS at 3 months).
What they're measuring
1
Proportion of patients with a good outcome at 3 months