Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Milrinone

Criteria

Inclusion Criteria:

• patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma 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 documented ischemic complication during the procedure of aneurysm treatment: transient or permanent arterial occlusion, visualization of a thrombus, and dissection of an axis requiring stenting.

• 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 <50ml / min)

• major hydroelectrolytic disorders (hypokalemia <3 mmol / L)

• known hypersensitivity to milrinone or any of the excipients

• pregnancy, breastfeeding

• permanent contraindications to MRI

• participation in another clinical study