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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
CHU Grenoble Alpes	La Tronche	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Centre Hospitalier Lyon Sud	Pierre Benite	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	25.07.2021

Trial locations

Investigated drugs:

Milrinone

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.

Investigated diseases:

Subarachnoid haemorrhage

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 ID:

2024-513410-35-00

Protocol code:

RC31/18/0472

NCT ID:

NCT04282629

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

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