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NCT04282629
Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
Conditions: Aneurysmal Subarachnoid Hemorrhage
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 234
Sponsor: University Hospital, Toulouse
Location: University Hospital Bordeaux Bordeaux
Summary
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
Inclusion Criteria:
* 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
* free patient, without tutorship or curatorship or under judicial protection
* obtaining a signed informed consent by a relative (or the person of trust) after clear and fair information about the study.
Exclusion Criteria:
* 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)
* known severe obstructive heart diseases
* flutter patient or atrial fibrillation
* hypotension and / or severe hypovolemia with hemodynamic instability
* septic shock
* acute / chronic renal insufficiency (Cl \
Source: ClinicalTrials.gov (NCT04282629). StuddyBuddy aggregates publicly available trial information.