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MIVAR - Milrinone Infusion for VAsospam treatment in subarachnoid hemoRrhage
EU CTIS ID: 2024-515994-83-00
What this study is testing
The main objective is to evaluate the efficacy of Milrinone intravenous infusion compare to placebo to improve the neurological outcome at 3 months in patients with vasospasm following an aneurysmal SAH.
- 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
- Adult patients hospitalized for aneurysmal subarachnoid hemorrhage
- Diagnosis of vasospasm confirmed on cerebral angiographic CT-scanner
- Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤ 6 hours
- Patients consent or patient’s relative (or emergency procedure)
You likely can't join if
- Initial Glasgow score = 3 with bilaterally mydriasis
- Non-affiliation to French health care coverage
- Pregnant, nursing or parturient woman
- Adult patient deprived of liberty by legal or administrative decision
- Adult patient with psychiatric care under duress
- Adult patient protected under the law (guardianship)
See the full eligibility criteria
- Adult patients hospitalized for aneurysmal subarachnoid hemorrhage
- Diagnosis of vasospasm confirmed on cerebral angiographic CT-scanner
- Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤ 6 hours
- Patients consent or patient’s relative (or emergency procedure)
- Initial Glasgow score = 3 with bilaterally mydriasis
- Non-affiliation to French health care coverage
- Pregnant, nursing or parturient woman
- Adult patient deprived of liberty by legal or administrative decision
- Adult patient with psychiatric care under duress
- Adult patient protected under the law (guardianship)
- Inclusion in an other interventional study modifying usual vasospasm management
- Moribund patient
- Contraindication to Milrinone (notably obstructive cardiomyopathy)
- Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment according to medical judgement)
- Cardiac failure needing ionotropic administration when randomization has to be performed
- Not controlled Intracranial Hypertension when randomization has to be performed
- (ICP > 25 mmHg during at least 20 min)
- Flutter patient or with cardiac aryhtmiaby atrial fibrillation poorly tolerated
- Major hydroelectric problems (hypokaliémia <3 mmol/L)
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, 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.