Study on Levosimendan for Treating Aneurysmal Subarachnoid Hemorrhage in Intensive Care Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Levosimendan in patients who have experienced a specific type of bleeding in the brain known as aneurysmal subarachnoid hemorrhage. This condition occurs when a blood vessel on the surface of the brain bursts, leading to bleeding in the space around the brain. The study aims to determine if adding Levosimendan to the usual care can help manage the acute phase of this condition.

Participants in the study will receive Levosimendan as a solution for infusion, which means it will be administered directly into the bloodstream through a drip. The study will also involve a comparison with a placebo to evaluate the effectiveness of the treatment. The main goal is to see if Levosimendan can reduce the risk of a complication called cerebral arterial vasospasm, which is a narrowing of the blood vessels in the brain that can occur after the initial bleeding.

The study will follow participants for a period of time to monitor the occurrence of vasospasms and other outcomes such as the rate of death, the impact on heart function, and recovery scores six months after treatment. This research is important to understand if Levosimendan can improve outcomes for patients with this serious condition.

1 joining the study

Upon joining the study, the patient is admitted to the surgical intensive care unit for treatment of subarachnoid hemorrhage of aneurysmal origin.

Eligibility is confirmed based on clinical scores (WFNS I to IV and Fisher score 3 or 4).

2 treatment initiation

The patient begins treatment with levosimendan, administered as a solution for infusion.

The dosage is 2.5 mg/ml, diluted for infusion, and is given in addition to usual care.

3 monitoring phase

The patient is monitored for the occurrence of cerebral arterial vasospasm within 14 days of the bleeding.

Regular assessments are conducted to evaluate the patient’s response to the treatment.

4 follow-up assessments

Secondary outcomes are measured, including the cumulative incidence of death rate, incidence of vasospasms, and the modified Rankin Scale (mRS) score at 6 months.

The impact of levosimendan on cardiac function is also assessed during this period.

5 completion of study

The study is estimated to conclude by October 14, 2025.

Final evaluations are conducted to determine the overall effectiveness of the treatment.

Who Can Join the Study?

Participants must be adults aged between 18 and 75 years old.
Participants must be hospitalized in a surgical intensive care unit for a subarachnoid hemorrhage. This is a type of bleeding in the space around the brain, caused by an aneurysm, which is a bulge in a blood vessel.
Participants must have a clinical score of WFNS Grade I to IV. This is a scale used to measure the severity of the condition, with I being the least severe and IV being more severe.
Participants must have a Fisher score of 3 or 4. This score is used to assess the amount of blood seen on a brain scan, with higher numbers indicating more blood.
Both male and female participants are eligible.

Who Cannot Join the Study?

Patients who have a different type of brain bleeding than the one being studied.
Patients who are not at high risk according to specific medical scales used to assess the severity of their condition.
Patients who are outside the specified age range for the study.
Patients who do not meet the gender requirements, as both males and females are eligible.
Patients who are considered part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	14.10.2023

Trial locations

Investigated drugs:

Levosimendan

Levosimendan is a medication being studied for its potential benefits in patients who have experienced a specific type of brain hemorrhage known as aneurysmal subarachnoid hemorrhage. This medication is being tested to see if it can improve outcomes when added to the usual care provided in intensive care settings. The goal is to determine if it can help reduce complications and improve recovery in patients at high risk of further vascular issues following the hemorrhage.

Investigated diseases:

Subarachnoid haemorrhage

Subarachnoid Hemorrhage of Aneurysmal Origin – This condition occurs when there is bleeding into the space surrounding the brain, often due to a ruptured aneurysm. The bleeding can increase pressure on the brain, leading to severe headaches, neck stiffness, and sensitivity to light. As the condition progresses, it may cause confusion, seizures, or loss of consciousness. The initial bleeding can also lead to complications such as cerebral arterial vasospasm, which can further reduce blood flow to the brain. This condition requires immediate medical attention to prevent further complications.

Trial ID:

2024-514242-36-00

Protocol code:

APHP200175

NCT ID:

NCT05664191

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Levosimendan for Treating Aneurysmal Subarachnoid Hemorrhage in Intensive Care Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?