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Study on Fibrinogen Replacement to Prevent Brain Bleeding in Stroke Patients After Thrombolysis

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 patients who have experienced an ischemic stroke, which is a type of stroke caused by a blockage in the blood vessels supplying blood to the brain. After receiving a treatment called thrombolysis, which helps dissolve blood clots, some patients may develop a condition known as hypofibrinogenemia. This condition occurs when there is a low level of fibrinogen in the blood, a protein that is essential for blood clotting. The study is investigating whether replacing fibrinogen with a medication called Riastap, which contains human fibrinogen, can help prevent bleeding in the brain, known as intracranial hemorrhage, in these patients.

The purpose of the study is to evaluate if fibrinogen replacement can prevent bleeding complications in patients with low fibrinogen levels after thrombolysis. Participants in the study will receive either the fibrinogen replacement treatment or a placebo. The study will monitor the effects of the treatment on the rate of bleeding in the brain and other parts of the body. It will also assess the safety of the treatment by checking for any serious side effects, such as blood clots in the veins or lungs, heart attacks, or another stroke.

Throughout the study, participants will be observed for changes in their condition, including their recovery from the stroke. The study will use tools like the National Institutes of Health Stroke Scale (NIHSS) to measure stroke severity and the modified Rankin Scale (mRS) to assess disability levels. The study aims to provide valuable information on whether fibrinogen replacement can improve outcomes for stroke patients with low fibrinogen levels after thrombolysis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: having an acute ischemic stroke treated with intravenous thrombolysis, being over 18 years old, and experiencing a significant drop in fibrinogen levels.
Written informed consent is required to proceed.
Step 2
Initial treatment
Initial treatment involves receiving a medication called rtPA, which is administered at a dose of 0.9 mg per kilogram of body weight.
This medication is given as 10% in a quick injection and 90% as an infusion over 60 minutes.
Step 3
Fibrinogen replacement therapy
If fibrinogen levels drop below 200 mg/dl or decrease by more than 50% from the baseline, a replacement therapy is initiated.
The therapy involves the administration of Riastap 1 g, a solution for injection or infusion, containing human fibrinogen.
This is given through a slow intravenous injection.
Step 4
Monitoring and evaluation
The effectiveness of the fibrinogen infusion is evaluated by monitoring for any reduction in the rate of intracranial hemorrhage and other bleeding complications.
Safety is assessed by checking for serious adverse events such as deep vein thrombosis, pulmonary embolism, or myocardial infarction within 7 days after randomization.
Step 5
Follow-up assessments
The clinical outcome is evaluated using the National Institutes of Health Stroke Scale score at day 7 and the modified Rankin Scale at 3 months.
A good outcome is defined as a modified Rankin Scale score between 0 and 2.
Step 6
Study duration
The study is expected to continue until June 2, 2025.
Recruitment for the study is anticipated to start on September 2, 2024.

Who can join the trial?

4 criteria

Patients must have had an acute ischemic stroke and received a treatment called i.v. thrombolysis (rtPA 0.9 mg/Kg, 10% in bolus and 90% in infusion over 60 minutes). This is a medication given through a vein to help dissolve blood clots.
Patients must be older than 18 years.
Patients must have critical hypofibrinogenemia after receiving tPA. This means their blood fibrinogen level, a protein that helps with blood clotting, has dropped to less than 200 mg/dl or decreased by more than 50% from their original level.
Patients must provide written informed consent, which means they agree to participate in the study after being informed about it.

Who cannot join the trial?

4 criteria

Patients who have had an ischemic stroke but do not have secondary post-rtPA hypofibrinogenemia. This means they do not have low levels of a blood protein called fibrinogen after receiving a specific stroke treatment.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria required for the study.

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Verified sites

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Azienda Ospedaliero Universitaria Di Modena
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Modena, Italy
Azienda Unita Sanitaria Locale Di Bologna
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Bologna, Italy

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Investigated drugs

Fibrinogen is a protein that helps in blood clotting. In this clinical trial, it is used to see if replacing fibrinogen can prevent bleeding in the brain for patients who have had a stroke and received a clot-busting treatment. The goal is to see if giving fibrinogen can help reduce the risk of bleeding complications after the treatment.

Human Fibrinogen

What is already known about the treatment

Fibrinogen – Fibrinogen is administered intravenously, typically as an infusion. It is currently being studied in clinical trials to assess its effectiveness in preventing bleeding complications in patients who have experienced an ischemic stroke and have low fibrinogen levels following thrombolysis treatment. The main therapeutic indication is to prevent intracranial hemorrhage in these patients. At the molecular level, fibrinogen works by being converted into fibrin by the enzyme thrombin, which helps in the formation of blood clots to stop bleeding. It is classified as a hemostatic agent, which means it helps to stop bleeding by promoting clot formation.

Investigated diseases

Ischemic Stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow and oxygen to brain tissue. This can result in the death of brain cells and loss of brain function. Symptoms may include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of an ischemic stroke can lead to further complications if not addressed promptly. In some cases, patients may experience secondary conditions such as hypofibrinogenemia, which is a reduction in fibrinogen levels following treatment with rtPA, a clot-dissolving medication. This condition can increase the risk of bleeding complications, both within the brain and elsewhere in the body.