Using Milrinone to treat vasospasm after subarachnoid hemorrhage

Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

This study is testing if giving Milrinone through an IV can help patients recover better from vasospasm after a brain bleed caused by an aneurysm.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Angers (other gov)
• Locations: 16 sites (Angers and 15 other locations)
• Trial ID: NCT04362527 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of intravenous Milrinone infusion in improving neurological recovery in patients suffering from vasospasm following an aneurysmal subarachnoid hemorrhage (SAH). It is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome is the proportion of patients achieving a good outcome, defined as a modified Rankin score of 2 or less, at three months post-treatment. The study aims to address a significant gap in the treatment of vasospasm, which currently lacks proven effective therapies.

Who should consider this trial

Good fit: Ideal candidates are adults hospitalized for their first episode of vasospasm following an aneurysmal SAH, diagnosed within six hours prior to inclusion.

Not a fit: Patients with severe initial Glasgow scores, moribund conditions, or contraindications to Milrinone will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes and quality of life for patients suffering from vasospasm after SAH.

How similar studies have performed: While there have been no randomized controlled trials specifically evaluating Milrinone for this indication, preliminary clinical cases suggest potential efficacy.

Eligibility criteria

Inclusion Criteria:

* Adult patients hospitalized for aneurysmal SAH
* First episode of vasospasm, with a diagnosis confirmed on cerebral arterial CT-scanner
* Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤6 hours

Exclusion Criteria:

* Initial Glasgow score at 3 with a bilateral mydriasis
* Moribund patient
* Pregnant woman
* Contraindication to Milrinone (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 in this case- according to medical judgement)
* Non-affiliation to French health care coverage,
* Adult patient protected under the law (guardianship)
* Cardiac failure necessitating inotropic agents
* Uncontrolled Intracranial hypertension (ICP\>25 mmHg for more than 20 min)
* Inclusion in an interventional study using Milrinone, or evaluating a treatment of cerebral vasospasm or with the same primary endpoint (mRS at 3 months).

Where this trial is running

Angers and 15 other locations

• CHU Angers — Angers, France (RECRUITING)
• CHU Besançon — Besançon, France (RECRUITING)
• CHU Bordeaux — Bordeaux, France (RECRUITING)
• CHU Brest — Brest, France (RECRUITING)
• CHU Caen — Caen, France (RECRUITING)
• Hôpital Gabriel Montpied — Clermont-Ferrand, France (RECRUITING)
• CHU Dijon — Dijon, France (TERMINATED)
• CHU Lille — Lille, France (RECRUITING)
• Hôpital Civils de Lyon — Lyon, France (RECRUITING)
• Hôpital Gui de Chauliac — Montpellier, France (TERMINATED)
• CHU Nantes — Nantes, France (RECRUITING)
• APHP Lariboisière — Paris, France (RECRUITING)
• Hôpital Fondation ROTHSCHILD — Paris, France (RECRUITING)
• CHU Rennes — Rennes, France (RECRUITING)
• Hôpital de Hautepierre — Strasbourg, France (RECRUITING)
• CHU Tours — Tours, France (RECRUITING)

Study contacts

• Principal investigator: Karim KL LAKHAL, PH — University Hospital of Nantes
• Study coordinator: Sigismond SL LASOCKI, PU-PH

Conditions: Vasospasm, Milrinone