Study on Reducing Inflammation in Acute Ischemic Stroke Patients Using Dornase Alfa and Sodium Chloride

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients who have experienced an ischemic stroke. An ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a reduction in blood flow and potentially leading to brain damage. The treatment being tested in this study involves the use of a medication called DNase, which is administered intravenously, meaning it is given directly into a vein. DNase is a type of enzyme that can break down certain proteins and is being investigated for its potential to reduce inflammation in the body after a stroke.

The purpose of this study is to determine if administering DNase can help lower the body’s immune response, which is often heightened after a stroke. This immune response is measured by looking at the levels of a specific protein in the blood called interleukin-1 beta (IL-1β). The study will compare the effects of DNase with a control treatment to see if there is a significant difference in the reduction of this protein.

Participants in the study will receive either the DNase treatment or a control treatment. The study will monitor the levels of interleukin-1 beta in the blood within 24 hours after the onset of stroke symptoms. The trial aims to provide insights into whether DNase can effectively reduce inflammation and improve outcomes for patients who have suffered an ischemic stroke. The study is expected to continue until the end of 2026.

1 joining the study

Participation begins after meeting specific criteria: suspected acute ischemic stroke, symptom onset to drug application within 12 hours, age 18 or older, and a National Institutes of Health Stroke Scale (NIHSS) score of 10 or more at admission.

Consent to participate is required.

2 initial assessment

An initial assessment is conducted to confirm eligibility and establish baseline measurements, including blood tests to measure interleukin-1 beta levels.

3 medication administration

The investigational drug, dornase alfa, is administered intravenously. This medication is intended to reduce systemic inflammation following an ischemic stroke.

The administration is performed as an intravenous bolus, which means the drug is given quickly through a vein.

4 monitoring and follow-up

Blood samples are taken within 24±6 hours after symptom onset to measure the concentration of interleukin-1 beta, which is a marker of inflammation.

The primary goal is to observe any reduction in systemic immune response compared to a control treatment.

5 data analysis

The collected data is analyzed using statistical methods to evaluate the effectiveness of the treatment in reducing inflammation.

Secondary outcomes are also assessed to provide additional insights into the treatment’s impact.

Who Can Join the Study?

Patients must have an urgent suspected acute ischemic stroke. This means a type of stroke where blood flow to a part of the brain is blocked suddenly.
The time from when the stroke symptoms started (last-seen-well) to when the study drug is given must be less than 12 hours.
Patients must agree to participate in the study, which means they need to give their consent.
Patients must be 18 years or older.
Patients must have a NIHSS score of 10 or higher at admission. The NIHSS is a scale used to measure the severity of a stroke, with higher numbers indicating more severe symptoms.

Who Cannot Join the Study?

Patients who have had a recent heart attack.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients with a history of severe allergic reactions to medications.
Patients currently participating in another clinical trial.
Patients with uncontrolled high blood pressure.
Patients with active cancer.
Patients with a history of bleeding disorders.
Patients who have had a recent surgery.
Patients with severe mental health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Uuchcmhpgs Mrckokq Cazinp Hvpaugcxqytqijtep	Hamburg	Germany
Kexizypr dig Uvzsxxdpbmzp Mwnhrbcg Auz	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	01.01.2025

Trial locations

Investigated drugs:

DNase 1 is a medication being tested in this clinical trial. It is administered intravenously to patients who have experienced an acute ischemic stroke. The purpose of using DNase 1 is to see if it can reduce the body’s immune response, specifically by lowering the levels of a substance in the blood called interleukin-1 beta. This reduction is measured 24 hours after the stroke symptoms begin. The trial aims to determine if DNase 1 can help manage inflammation in the body following a stroke.

Investigated diseases:

Ischaemic stroke

Ischemic Stroke – Ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes, leading to potential loss of brain function. Symptoms often 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 vary, with some individuals experiencing a gradual worsening of symptoms, while others may have a sudden onset. The extent of brain damage and recovery can depend on the location and duration of the blockage. Early intervention is crucial to minimize long-term effects.

Trial ID:

2024-516701-22-00

Protocol code:

RESCIND-1-2023

NCT ID:

NCT05880524

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Reducing Inflammation in Acute Ischemic Stroke Patients Using Dornase Alfa and Sodium Chloride

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?