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Study on Reducing Ischemic Stroke Damage with Low-Dose Human Albumin Solution and Sodium Chloride in Adult Patients

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 treatment for ischemic stroke, a condition where blood flow to the brain is reduced, leading to potential brain damage. The study will use a treatment involving human albumin solution, a protein found in blood, which will be administered in low doses. The purpose of the study is to evaluate how effective albumin is in protecting the blood vessels in the brain during a stroke.

Participants in the study will receive either the albumin treatment or a placebo. The treatment will be given through an infusion, which means it will be delivered directly into the bloodstream. The study will monitor the participants over a period of time to observe any changes in their condition, particularly focusing on the size of the brain lesion caused by the stroke and the overall recovery of the patient.

The study aims to gather information on the concentration of certain substances in the blood and urine, which can indicate the level of protection provided by the albumin. Additionally, the study will assess the participants' recovery using various scales and tests, such as the Modified Rankin Scale (mRS), which measures the degree of disability or dependence in daily activities. The study will also track the participants' health status up to 90 days after the treatment to evaluate long-term effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, consent to participate is required. This can be provided by you or an independent physician, depending on your medical condition.
Eligibility includes being 18 years or older, having a diagnosis of ischemic stroke in the anterior circulation, and an indication for a vasographic intervention at a stroke center.
Step 2
Medication administration
You will receive two types of infusions: sodium chloride and human albumin solution. These are solutions administered directly into your bloodstream.
The purpose of the albumin infusion is to protect the endothelial glycocalyx, which is a part of your blood vessels, and to support their function.
Step 3
Monitoring and testing
Throughout the trial, the concentration of certain substances in your blood and urine will be measured. These include syndecan-1 in your blood serum and GAG in your urine.
Your neurological condition will be assessed at the start of the trial and again on Day 7 or before you are discharged or transferred from the hospital.
Step 4
Follow-up assessments
On Day 90, your overall health and recovery will be evaluated. This includes checking the size of the ischemic brain lesion using imaging techniques like CT or MRI.
Your recovery will also be assessed using the Modified Rankin Scale (mRS), which measures the degree of disability or dependence in daily activities.

Who can join the trial?

5 criteria

Age must be 18 years or older.
The patient or an independent doctor must provide consent to participate in the study. This depends on the patient's health condition.
The patient must have a diagnosis of ischemic stroke in the front part of the brain's blood circulation. This can be with or without a treatment called thrombolysis, which helps dissolve blood clots.
The patient must need a vasographic intervention, which is a procedure to open blocked blood vessels, at a stroke center.
For women who can have children: Must be willing to use highly effective birth control methods during the study and until 21 days after receiving the study medication. Given the health condition of the patients, complete sexual abstinence is suggested as the best option.

Who cannot join the trial?

3 criteria

Patients who have had an ischemic stroke cannot participate. An ischemic stroke is when a blood clot blocks or narrows an artery leading to the brain.
Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Fakultni Nemocnice Hradec Kralove
Novy Hradec Kralove, Czechia

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Investigated drugs

Albumin is a protein that is naturally found in your blood. In this clinical trial, it is used to help protect the tiny blood vessels in the brain. These blood vessels have a special lining called the glycocalyx, which can be damaged during a stroke. By giving albumin, the trial aims to see if it can help protect this lining and improve blood flow, potentially reducing brain damage after a stroke.

What is already known about the treatment

Albumin – Albumin is administered intravenously, meaning it is given directly into a vein through an injection or infusion. Currently, albumin is being studied for its potential to protect the lining of blood vessels in the brain, particularly in cases of ischemic stroke, which is a type of stroke caused by a blockage in the blood supply to the brain. The main therapeutic indication for albumin in this context is to reduce brain damage by safeguarding the endothelial glycocalyx, a protective layer on blood vessels. At the molecular level, albumin works by maintaining the integrity of this glycocalyx, which helps in preserving normal blood vessel function. Albumin is classified pharmacologically as a plasma expander, which means it helps to increase the volume of blood plasma.

Investigated diseases

Ischemic stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, reducing blood flow and oxygen supply. This blockage can result from a clot that forms in the brain's blood vessels or travels from another part of the body. As the brain cells are deprived of oxygen, they begin to die, leading to the loss of brain function in the affected area. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, and difficulty walking. The progression of the disease can lead to further brain damage if blood flow is not restored quickly. Over time, the affected individual may experience varying degrees of recovery or permanent impairment, depending on the severity and location of the stroke.