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Active Not Recruiting 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 \

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Source: ClinicalTrials.gov (NCT04282629). StuddyBuddy aggregates publicly available trial information.