Study on Stereotactic Cisternal Lavage Therapy for Patients with Aneurysmal Subarachnoid Hemorrhage Using Urokinase, Nimodipine, and a Drug Combination

2 1 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Aneurysmal Subarachnoid Hemorrhage (aSAH), which is a type of bleeding in the space around the brain caused by a burst blood vessel. The study aims to explore a treatment method called cisternal lavage therapy, which involves washing out the area around the brain using a special solution. The treatment includes the use of Urokinase, a medication that helps break down blood clots, and Nimodipine, a drug that helps prevent further brain injury by relaxing blood vessels. These medications are administered through a small tube placed in the brain area affected by the bleeding.

The purpose of this study is to determine if this treatment can improve the recovery and safety of patients who have experienced aSAH. Participants in the study will receive either the treatment with Urokinase and Nimodipine or a placebo. The study will monitor patients over a period of time to assess their neurological recovery, which refers to how well their brain functions after the treatment. This will be evaluated by a healthcare professional using a scale that measures independence in daily activities.

Throughout the study, various aspects of the patients’ health will be observed, including their quality of life, mental health, and any potential side effects of the treatment. The study will also look at the occurrence of any further brain damage or complications. The goal is to gather information that could lead to better treatment options for individuals suffering from aSAH in the future.

1 initial treatment setup

Upon joining the study, a catheter is implanted into the prepontine cistern. This is done using a precise method called stereotactic surgery.

The catheter is used to deliver medications directly to the area around the brain where the hemorrhage occurred.

2 medication administration

The treatment involves the administration of several medications through the catheter.

The medications include urokinase, nimodipine, calcium chloride dihydrate, potassium chloride, and sodium chloride. All are administered intrathecally, meaning they are delivered directly into the space around the brain and spinal cord.

The purpose of these medications is to help prevent further brain injury after the initial hemorrhage.

3 monitoring and follow-up

Throughout the trial, neurological outcomes are assessed at various intervals to determine the effectiveness of the treatment.

Primary assessments occur at 6 months after the hemorrhage, with additional evaluations at 12 months.

Secondary outcomes include assessments of quality of life, psychological health, and any potential complications such as delayed cerebral infarction or ischemic deficits.

4 safety and adverse events

The safety of the treatment is closely monitored. Any adverse events related to the investigational treatment are recorded and analyzed.

The goal is to ensure that the treatment is not only effective but also safe for patients.

Who Can Join the Study?

Patients must be male or female and aged 18 years or older but less than 80 years.
Patients should have a Modified Fisher grade of 3 or 4. This is a way to measure the amount of blood in the brain after a bleeding event.
The amount of blood in the brain, measured by the Hijdra Score, should be 20 or more. This score helps to assess the severity of bleeding.
Patients should have a WFNS grade of 3 or higher. This is a scale used to evaluate the patient’s condition after a brain bleed. If the grade is 5, the patient can only participate if they have a fixed dilated pupil due to increased pressure in the brain for less than 45 minutes.
Patients must have an external ventricular drain (EVD) in place or need one. An EVD is a tube used to relieve pressure in the brain.
The disease should have started 96 hours or less before the patient is chosen for the study.
Written informed consent must be provided by the patient or their legally authorized representative. This means they agree to participate in the study after understanding what it involves.
The source of the bleeding must be a cerebral aneurysm, which is a bulge in a blood vessel in the brain.
The cerebral aneurysm must have been safely treated using either open surgery or an endovascular technique. Endovascular technique is a less invasive procedure that involves treating the aneurysm from inside the blood vessel.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	17.07.2019

Trial locations

Investigated drugs:

Urokinase is a medication used in this trial to help break down blood clots. It is administered directly into the brain area affected by bleeding to help clear the blood and reduce pressure on the brain, potentially improving recovery after a brain hemorrhage.

Nimodipine is used in this trial to help prevent further brain injury after a hemorrhage. It works by relaxing blood vessels in the brain, which can help improve blood flow and reduce the risk of complications following a brain bleed.

Ringer’s Solution is a fluid used in this trial to help maintain the balance of fluids and electrolytes in the body. It is administered directly into the brain area to support the other treatments and help ensure the brain has the necessary environment to heal.

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 begins suddenly with a severe headache, sometimes described as the worst headache ever experienced. As the bleeding progresses, it can cause symptoms such as neck stiffness, nausea, vomiting, and sensitivity to light. In some cases, it may lead to loss of consciousness or neurological deficits. The bleeding can increase pressure on the brain, potentially causing further complications. Over time, the body may reabsorb the blood, but the initial bleeding can lead to significant neurological impact.

Trial ID:

2024-517798-25-00

Protocol code:

P001151

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Stereotactic Cisternal Lavage Therapy for Patients with Aneurysmal Subarachnoid Hemorrhage Using Urokinase, Nimodipine, and a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?