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Cerebral hemodynamic optimization by milrinone for the prevention of delayed cerebral ischemia in severe subarachnoid hemorrhage
EU CTIS ID: 2024-513410-35-00
What this study is testing
The main objective is to evaluate, in patients with 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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - patients with severe SAHa (WFNS IV and V)
- - 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.
You likely can't join if
- - patients with non-severe SAHa (WFNS I, II and III)
- - 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
See the full eligibility criteria
- - patients with severe SAHa (WFNS IV and V)
- - 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.
- - patients with non-severe SAHa (WFNS I, II and III)
- - 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 pharmacological study that may interfere with the objective of the study
- - 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.