Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia (NCT04282629) | Clinical Trial Compass
RecruitingPhase 2
Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
France234 participantsStarted 2021-07-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<50ml / min)
* major hydroelectrolytic disorders (hypokalemia \<3 mmol / L)
* known hypersensitivity to milrinone or any of the excipients
* early limitation of life-sustaining care
* pregnancy, breastfeeding
* permanent contraindications to MRI
* participation in another clinical interventional study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.