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Study on the Effectiveness of Dornase Alfa for Improving Blood Flow in Patients with Ischemic Stroke Eligible for Thrombectomy

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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 medication called dornase alfa, also known by its brand name Pulmozyme, in 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. The study aims to evaluate how effective dornase alfa is when given intravenously, meaning directly into a vein, in helping to reopen arteries after a procedure called thrombectomy. Thrombectomy is a treatment used to remove blood clots from the brain's blood vessels.

Participants in this study will have already received a treatment called thrombolysis, which involves using medication to dissolve blood clots. The study will observe how well dornase alfa works in improving blood flow in the brain after thrombectomy. The trial will involve monitoring the participants' recovery and checking the blood flow in their brain using a special imaging technique called angiography, which provides a detailed view of the blood vessels.

The purpose of this study is to determine if dornase alfa can help improve the outcomes for patients who have had an ischemic stroke and are undergoing thrombectomy. The trial will last for a certain period, during which participants will be closely monitored for any changes in their condition and any side effects from the treatment. The results of this study could provide valuable information on the potential benefits of using dornase alfa in stroke treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon arrival at the hospital, eligibility for the study is assessed. This includes being over 18 years old, having an ischemic stroke due to a specific type of artery blockage, and having received certain treatments.
Consent to participate in the study is required. If the patient is unable to provide consent, a trusted person or family member may do so.
Step 2
Initial treatment
The patient receives intravenous thrombolysis, which is a treatment to dissolve blood clots. This is done according to specific medical guidelines.
Step 3
Administration of study medication
The study involves the administration of dornase alfa (Pulmozyme®) through an intravenous infusion. This medication is intended to help with the recanalization of arteries, which means reopening blocked blood vessels.
Step 4
Thrombectomy procedure
A thrombectomy is performed, which is a procedure to remove the blood clot from the artery. The effectiveness of the procedure is assessed using a scoring system called the TICI score.
Step 5
Post-procedure assessment
After the thrombectomy, cerebral angiography is used to evaluate the success of the procedure. This involves imaging the blood vessels in the brain to check for recanalization.
If the procedure is completed within one hour of starting the dornase alfa infusion, a second angiography may be performed to further assess the TICI score.
Step 6
Follow-up evaluations
Within 24 to 36 hours after the procedure, a brain MRI is conducted to measure the volume of any cerebral infarct, which is an area of dead tissue due to lack of blood supply.
A brain scan is also performed to check for any hemorrhagic transformation, which is bleeding in the brain, using a specific scale.
Step 7
Long-term follow-up
Three months after the stroke, the patient's functional prognosis is evaluated using a modified Rankin score, which measures the degree of disability or dependence in daily activities.
The study also monitors for any adverse events or reactions related to the treatment.

Who can join the trial?

7 criteria

The patient must be over 18 years old.
The patient must have had an ischemic stroke caused by a blockage in a large blood vessel in the brain, specifically in the internal carotid artery or the middle cerebral artery in its M1 segment. This type of stroke affects the front part of the brain and the patient must be eligible for a procedure called cerebral thrombectomy, which is a treatment to remove the blockage.
The patient must have been urgently transferred to the NRI unit at the Fondation Adolphe de Rothschild Hospital for the cerebral thrombectomy procedure.
The patient must have been treated with a medication called intravenous thrombolysis (using drugs like Alteplase or Tenecteplase) according to the 2021 guidelines of the European Stroke Organisation. This treatment should have started with a quick injection (bolus) less than 90 minutes before joining the study.
The patient must have a DWI-ASPECT score of 5 or higher on an initial brain MRI. This score helps doctors understand the extent of the stroke damage in the brain.
The patient must have received complete information about the study and signed a consent form to participate. If the patient is unable to provide consent, a trusted person or family member can do so. In emergencies, a doctor may include the patient following special procedures.
The patient must be a member or beneficiary of a social security scheme.

Who cannot join the trial?

7 criteria

Patients who have had a recent **ischemic stroke**. An ischemic stroke happens when a blood vessel in the brain is blocked, stopping blood flow.
Patients who are not eligible for **thrombectomy**. Thrombectomy is a procedure to remove a blood clot from a blood vessel.
Patients who are not eligible for **thrombolysis**. Thrombolysis is a treatment to dissolve dangerous clots in blood vessels.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.

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Fondation A De Rothschild
Paris, France

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Investigated drugs

Dornase alfa (Pulmozyme®) is a medication used in this clinical trial to help improve blood flow in patients who have had a stroke. It is given through an intravenous injection, which means it is delivered directly into the bloodstream. The goal of using this medication is to see if it can help open up the arteries after a procedure called thrombectomy, which is used to remove blood clots in patients who have experienced an ischemic stroke.

Dornase Alfa

What is already known about the treatment

Dornase Alfa (Pulmozyme®) – This medication is administered intravenously and is currently being evaluated in clinical trials for its effectiveness in treating ischemic stroke. It is primarily used to help with arterial recanalization following thrombectomy procedures. Dornase alfa works by breaking down DNA in the mucus, which can help clear blockages in blood vessels. It is classified as a mucolytic agent, typically used in cystic fibrosis, but is being explored for new therapeutic uses in stroke management.

Investigated diseases

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 function in the affected area. 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 rapid onset of symptoms, while others may have a more gradual development. Immediate medical attention is crucial to minimize brain damage and improve outcomes. The condition is not classified as a rare disease.