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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Fondation A De Rothschild Paris France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Cuiqgw Hqnndtmkyfd Utoidqqgsptkp Dl Davap Dijon France
Bbftgabb Uwmowockzo Hhecdfxf Ccwqjs Besançon France
Cxojgy Hdpyxedsvir Ravtaisc Upeuppszxwzyb Dg Takur Tours France
Cgokwx Hinyhxdytkt Rutrvspn Dessucnxcthdyb Angers France
Hruwpfcp Uzhsyeyonzqwkq Sbcmldbmyb &tmsiqb Hbjdhmm dc Hnomagxhokf STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
10.08.2020

Trial locations

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.

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 ID:
2024-515994-83-00
Protocol code:
49RC19_0016
NCT ID:
NCT04362527
Trial Phase:
Therapeutic confirmatory (Phase III)

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