About this trial
The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma (Glasgow coma score of 8 or less) or need for sedation at D3
absence of pre-existing neurological handicap (mRS 0-2)
major patient (≥ 18 years)
affiliation to social security or benefiting through a third person
Disqualifiers
patients with non-severe SAHa (WFNS I, II and III)
Occurrence of a major complication (haemorrhagic or ischaemic) documented during the procedure of securing the aneurysm and endangering the short-term vital prognosis
heart failure requiring inotropic administration at the time of randomization
ICHT at the time of randomisation (ICP> 25 mmHg for at least 20 min)
Trial design
Parallel
Treatments tested in this trial
Milrinone Injection
Drugadministration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14
Placebo
Other interventionadministration of placebo (intravenous glucose 5%) from Day 4 to Day 14
Treatment groups
Trial outcomes
Primary outcomes
volume of delayed cerebral ischemia lesions
volume of DCI lesions measured on CT scan and validated by Magnetic Resonance Imaging (MRI) imaging at 1 month
Secondary outcomes
Radiological parameters on CT at 1 month
percentage of patients with DCI lesions
Evolution in intensive care: Neurological complications 1
number of episodes of PtiO2 below the ischemic threshold in intensive care: PtiO2 \<20 mmHg (moderate hypoxia) and \<15 mm Hg (severe hypoxia) for at least 15 minutes
Evolution in intensive care: Neurological complications 2
total duration of episodes of PtiO2 \<20 mm Hg (moderate hypoxia) and \<15 mm Hg (severe hypoxia)
Evolution in intensive care: Neurological complications 3
number of recourse to an endovascular treatment
Sponsors and contacts
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