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Study on Milrinone Infusion for Treating Vasospasm in Patients with Aneurysmal Subarachnoid Hemorrhage

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Milrinone on a condition known as vasospasm that can occur after an aneurysmal subarachnoid hemorrhage. An aneurysmal subarachnoid hemorrhage is a type of bleeding in the brain that happens when a blood vessel bursts. Vasospasm is a complication where the blood vessels in the brain narrow, which can lead to further brain damage.

The purpose of the study is to evaluate how effective Milrinone, given through an intravenous infusion, is compared to a placebo in improving the neurological outcomes of patients three months after experiencing vasospasm following an aneurysmal subarachnoid hemorrhage. Participants in the study will receive either the Milrinone treatment or a placebo, and their progress will be monitored over a period of time to assess their recovery and overall health outcomes.

Throughout the study, various aspects of the participants' health will be evaluated, including their recovery in terms of brain function and quality of life. The study will also look at the success of the treatment in terms of reducing the narrowing of blood vessels in the brain, as well as other health indicators such as the length of hospital stay and any changes in blood pressure or metabolism. The goal is to gather information that could help improve treatment strategies for patients with this serious condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after a diagnosis of aneurysmal subarachnoid hemorrhage with a vasospasm is confirmed using a cerebral angiographic CT scan.

    Inclusion in the study must occur within 6 hours of the vasospasm diagnosis.

    Consent is required from the patient or a relative.

  2. Step 2

    Treatment administration

    The treatment involves an intravenous infusion of Milrinone, a medication used to treat vasospasm.

    Milrinone is administered as a solution for injection, specifically at a concentration of 1 mg/ml.

    The infusion is compared to a placebo to assess its effectiveness in improving neurological outcomes.

  3. Step 3

    Monitoring and evaluation

    The primary goal is to evaluate the proportion of patients with a good outcome at 3 months, defined by a modified Rankin score of 2 or less.

    Secondary evaluations include mortality rates in the intensive care unit, hospital, and at 3 and 6 months post-aneurysm rupture.

    Long-term clinical outcomes are assessed using the modified Rankin score and the Glasgow Outcome Scale Extended at 3 and 6 months.

  4. Step 4

    Quality of life assessment

    Quality of life is measured using the EQ-5D scale at baseline, 3 months, and 6 months.

    The effectiveness of the treatment is also evaluated through radiologic assessments, including angiographic success and the volume of infarcted areas.

  5. Step 5

    Hospitalization and tolerance evaluation

    The length of hospitalization in the intensive care unit and hospital, including recovery centers, is recorded.

    Hemodynamic tolerance is assessed by the need to introduce or increase doses of catecholamines by 50% during the first 24 hours.

    Metabolic tolerance is evaluated by monitoring the occurrence of dysnatremia and daily urine output.

Who can join the trial?

5 criteria

  • Must be an adult patient who is in the hospital for an aneurysmal subarachnoid hemorrhage. This is a type of bleeding in the brain caused by a bulging blood vessel.
  • Must have a diagnosis of vasospasm, which is a condition where blood vessels in the brain narrow, confirmed by a special brain scan called a cerebral angiographic CT-scanner.
  • The time between the diagnosis of vasospasm and joining the study must be 6 hours or less.
  • Must have given consent to participate, or a relative must have given consent if the patient is unable to do so, or through an emergency procedure.
  • Both male and female patients can participate.
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Investigated drugs

Milrinone is a medication used in this clinical trial to treat vasospasm, which is a condition where blood vessels constrict and reduce blood flow. This can happen after a type of bleeding in the brain called subarachnoid hemorrhage. The trial is testing whether giving Milrinone through an intravenous infusion can help improve the neurological outcomes of patients three months after experiencing this condition.

What is already known about the treatment

Milrinone – Milrinone is administered as an intravenous infusion, typically used in a hospital setting. It is currently being studied in clinical trials for its effectiveness in treating vasospasm following an aneurysmal subarachnoid hemorrhage. The main therapeutic indication for Milrinone in this context is to improve neurological outcomes in patients experiencing vasospasm. At the molecular level, Milrinone works by inhibiting an enzyme called phosphodiesterase 3, which leads to an increase in cyclic AMP levels, resulting in vasodilation and improved blood flow. It is classified pharmacologically as a phosphodiesterase inhibitor.

Investigated diseases

Aneurysmal Subarachnoid Hemorrhage with Vasospasm – This condition occurs when a blood vessel in the brain bursts, leading to bleeding in the space surrounding the brain, known as the subarachnoid space. The rupture of an aneurysm is the primary cause of this hemorrhage. Following the initial bleeding, blood vessels in the brain may constrict, a process called vasospasm, which can reduce blood flow and lead to further brain injury. Symptoms often include a sudden, severe headache, neck stiffness, and sensitivity to light. As the condition progresses, it can cause neurological deficits due to reduced blood supply to brain tissues. Monitoring and managing the vasospasm is crucial to prevent additional complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515994-83-00Protocol code49RC19_0016Estimated enrolment370 patientsSponsorCentre Hospitalier Universitaire D'Angers

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