Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Milrinone for Preventing Delayed Brain Ischemia in Patients with Severe Subarachnoid Hemorrhage

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying a condition known as aneurysmal subarachnoid hemorrhage, which is a type of bleeding that occurs in the space around the brain. The study aims to explore the effects of a medication called milrinone, which is administered as a solution for injection or infusion. Milrinone is being tested to see if it can help prevent a complication called delayed cerebral ischemia, which is a reduction in blood flow to the brain that can occur after the initial bleeding event.

Participants in the study will receive either milrinone or a placebo, in addition to their usual medical care, for a period of 10 days. The main goal is to assess the impact of milrinone on the size of any brain lesions, which are areas of damaged tissue, as seen on a CT scan one month after treatment. A CT scan, or computed tomography scan, is a type of imaging that helps doctors see inside the body. The study will also monitor other factors, such as the number of days spent in intensive care and any changes in brain function over time.

Throughout the study, researchers will collect information on various health outcomes, including the overall neurological health of participants at different time points, such as one month, three months, six months, and one year after treatment. This will help determine the long-term effects of milrinone on patients who have experienced a severe aneurysmal subarachnoid hemorrhage. The study is expected to continue until 2028, providing valuable insights into the potential benefits of milrinone for 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

    Upon joining the study, the patient must meet specific criteria, including having a severe subarachnoid hemorrhage, being 18 years or older, and not having a pre-existing neurological handicap.

    A signed informed consent is required from a relative or a trusted person after receiving clear information about the study.

  2. Step 2

    Treatment phase

    The treatment involves the administration of milrinone through an infusion. This is a solution for infusion that is given to the patient over a period of 10 days.

    The purpose of this treatment is to evaluate its effect on preventing delayed cerebral ischemia, which is a condition that can occur after a subarachnoid hemorrhage.

  3. Step 3

    Monitoring and evaluation

    During the trial, the patient will undergo regular monitoring to assess the volume of delayed cerebral ischemia lesions using a CT scan at 1 month.

    Additional evaluations include monitoring neurological and non-neurological complications, changes in cerebral and general blood flow, and the number of days spent in intensive care and on mechanical ventilation.

  4. Step 4

    Follow-up assessments

    Follow-up assessments will be conducted at 1 month, 3 months, 6 months, and 1 year to evaluate neurological outcomes using the modified Rankin score and the Glasgow Outcome Scale.

    Quality of life will be assessed using the Sickness Impact Profile scale at 3 months, 6 months, and 1 year.

  5. Step 5

    Biomarker collection

    A biocollection will be established to evaluate plasma brain biomarkers or other potential biomarkers, which may provide additional insights into the patient's condition and response to treatment.

Who can join the trial?

6 criteria

  • Patients must have a severe form of **aneurysmal subarachnoid hemorrhage**. This is a type of bleeding in the brain caused by a bulging blood vessel.
  • Patients should not have any pre-existing **neurological handicap**. This means they should not have any previous brain or nerve problems that affect their daily life, as measured by a scale called **mRS** (Modified Rankin Scale) with scores between 0 and 2.
  • Patients must be **18 years or older**.
  • Patients need to be affiliated with social security or have similar benefits through someone else.
  • Patients must be free individuals, meaning they are not under any legal guardianship or judicial protection.
  • A signed **informed consent** must be obtained from a relative or a trusted person. This means someone close to the patient agrees to the study after being given clear and fair information about it.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of brain bleeding than the one being studied.
  • Patients who are not in the severe category of the condition being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medication.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of certain heart conditions that could be affected by the study medication.
  • Patients who have severe kidney problems.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Milrinone is a medication used in this study to help improve blood flow in the brain. It is being tested to see if it can prevent delayed cerebral ischemia, which is a type of brain injury that can occur after a severe subarachnoid hemorrhage, a kind of bleeding in the brain. The study is looking at how well milrinone works over a period of 10 days, in addition to the usual care that patients receive.

What is already known about the treatment

Milrinone – Milrinone is administered intravenously and is currently being studied for its potential benefits in patients with severe subarachnoid hemorrhage, specifically to prevent delayed cerebral ischemia. It is a phosphodiesterase inhibitor that works by increasing the levels of cyclic AMP in cells, leading to vasodilation and improved blood flow. This medication is primarily used in the treatment of heart failure, but its application in cerebral conditions is under investigation. The OPTIMIL Study is exploring its effectiveness in reducing brain damage following aneurysmal subarachnoid hemorrhage.

Investigated diseases

Aneurysmal Subarachnoid Hemorrhage – This condition occurs when a blood vessel on the surface of the brain bursts, leading to bleeding in the space between the brain and the surrounding membrane. It often results from a weakened area in a blood vessel wall, known as an aneurysm. The bleeding can increase pressure on the brain, leading to symptoms such as a sudden severe headache, neck stiffness, and sensitivity to light. As the condition progresses, it may cause neurological complications due to reduced blood flow to the brain, known as delayed cerebral ischemia (DCI). This can result in further brain injury if not managed promptly. The condition requires careful monitoring and management to prevent further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513410-35-00Protocol codeRC31/18/0472Estimated enrolment100 patientsSponsorCentre Hospitalier Universitaire De Toulouse

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).