Study on the Effects of Dornase Alfa for Patients with Subarachnoid Hemorrhage to Improve Independence After 6 Months

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dornase alfa on patients who have experienced a subarachnoid hemorrhage. A subarachnoid hemorrhage is a type of bleeding that occurs in the space around the brain, often due to a ruptured blood vessel. The treatment being tested involves the daily administration of dornase alfa through an intravenous (IV) infusion for up to 14 days following the hemorrhage.

The purpose of the study is to evaluate whether this treatment can improve the chances of patients achieving a good level of independence in their daily activities six months after the hemorrhage. Participants in the study will receive either the dornase alfa treatment or a placebo, and their progress will be monitored over time. The study aims to determine if the treatment can lead to better recovery outcomes compared to those who do not receive it.

Throughout the study, participants will undergo various assessments, including evaluations of their neurological function and brain imaging tests like MRI scans. These assessments will help researchers understand the impact of the treatment on the brain and overall recovery. The study will also track any side effects or complications that may arise during the treatment period. The ultimate goal is to see if dornase alfa can help improve recovery and quality of life for patients who have suffered a subarachnoid hemorrhage.

1 joining the study

Participation begins after hospital admission for a subarachnoid hemorrhage caused by a ruptured aneurysm.

Symptoms must have started less than 48 hours before joining the study.

The aneurysm must be effectively excluded within the last 24 hours, with no complications confirmed by a CT scan.

2 treatment administration

Receive a daily intravenous (IV) infusion of dornase alfa.

The dosage is 125 micrograms per kilogram of body weight.

This treatment continues for up to 14 days after the hemorrhage.

3 monitoring and assessments

Functional prognosis is assessed at 6 months using the modified Rankin Scale (mRS). A score of 0 or 1 indicates an excellent prognosis.

Additional assessments include checking for neurological deficits, changes in the Glasgow score, and ischaemic lesions on MRI at 21 days post-hemorrhage.

Other evaluations involve treatment of vasospasm, number of treatment days, MoCA-5min score, and all-cause mortality at 21 days.

4 follow-up

Follow-up includes a centralised assessment by telephone by a certified professional who is unaware of the treatment group.

MRI scans are analysed centrally by a radiologist who is also unaware of the treatment group.

Changes in NETs blood concentration are measured between the start of the study and 21 days post-hemorrhage.

Who Can Join the Study?

Patient must be aged 18 or over.
Patient must be admitted to the hospital for a subarachnoid hemorrhage (SAH), which is bleeding in the space around the brain, caused by a ruptured aneurysm.
The symptoms of SAH must have started less than 48 hours ago.
The aneurysm must have been effectively excluded, meaning it has been treated to prevent further bleeding, within the last 24 hours.
There must be no complications during the procedure to exclude the aneurysm, confirmed by a CT scan, which is a type of detailed X-ray of the brain.
The Fisher score, which is a way to measure the amount of blood seen on a brain CT scan, must be greater than 1 on the initial scan before the aneurysm is treated.
Patient must be a beneficiary of a social protection scheme, meaning they have some form of health insurance or social security.
Informed consent must be signed by the patient or by a family member or trusted support person if the patient cannot give consent themselves. In emergency situations, if no family or support person is available, the patient can be included, and consent will be sought as soon as the patient is able to provide it.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Pellegrin Hospital	Bordeaux	France
Fondation A De Rothschild	Paris	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hospices Civils De Lyon	Lyon	France
Clig Dr Neans	Vandoeuvre Les Nancy	France
Hxxnvmau Uihbwstlmzukxg Seikzqnqla &wljuiv Hrgqmiz dl Hshvpmwmefp	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.06.2025

Trial locations

Investigated drugs:

Dornase Alfa

Dornase alfa is a medication being tested in this clinical trial. It is given through an IV (intravenous) infusion daily for up to 14 days after a subarachnoid hemorrhage, which is a type of bleeding in the brain. The goal of using this medication is to see if it can help improve the patient’s ability to function independently six months after the hemorrhage.

Investigated diseases:

Aneurysm ruptured

Subarachnoid Hemorrhage – This condition occurs when there is bleeding in the space between the brain and the surrounding membrane, known as the subarachnoid space. It is often caused by a ruptured aneurysm, which is a weakened area in a blood vessel. The bleeding can lead to increased pressure on the brain, causing severe headaches, neck stiffness, and sensitivity to light. As the condition progresses, it may result in confusion, seizures, or loss of consciousness. The bleeding can also cause complications such as vasospasm, where blood vessels constrict, potentially leading to further brain injury. Recovery and symptoms can vary widely depending on the severity and location of the hemorrhage.

Trial ID:

2023-509627-40-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Dornase Alfa for Patients with Subarachnoid Hemorrhage to Improve Independence After 6 Months

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?