Study on Norepinephrine for Improving Outcomes in Patients with Acute Progressive Stroke

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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, which is a type of stroke caused by a blockage in the blood vessels supplying blood to the brain. The treatment being tested involves the use of a medication called norepinephrine, which is administered through an intravenous infusion. Norepinephrine is a chemical that can help increase blood pressure, and in this study, it is used in a diluted form to potentially improve the outcomes for patients who are experiencing neurological deterioration during the acute phase of their stroke.

The purpose of the study is to determine if adding norepinephrine to the standard care for stroke patients can improve their recovery and functional independence after 90 days. Participants in the study will receive either the standard care alone or the standard care plus the norepinephrine infusion. The study will monitor the patients’ progress over a period of 90 days to assess their recovery and any changes in their condition.

Throughout the study, various aspects of the patients’ health will be evaluated, including their neurological improvement, any side effects from the treatment, and their overall well-being. The goal is to see if the use of norepinephrine can lead to better outcomes for patients who have suffered from an acute ischemic stroke, potentially offering a new approach to treatment that could enhance recovery and quality of life.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as having an acute ischemic stroke within 72 hours, experiencing early neurological deterioration, and being at least 18 years old.

Women of childbearing potential must use contraception during the study.

2 randomization

Participants are randomly assigned to receive either standard care or standard care plus norepinephrine.

The time between early neurological deterioration and randomization must be less than 6 hours.

3 treatment administration

If assigned to the norepinephrine group, the medication is administered intravenously as a solution for infusion.

The goal is to achieve a target blood pressure for at least 24 hours.

4 monitoring and assessment

During the infusion, regular monitoring is conducted to assess blood pressure and any potential side effects such as headache, chest pain, or changes in heart rate.

The infusion is evaluated by a stroke neurologist, and adjustments are made as necessary.

5 follow-up evaluations

Functional independence is assessed at 90 days using the modified Rankin Scale (mRS).

Additional evaluations include cognitive assessments and screening for anxiety and depression.

6 completion of the study

The study concludes with a final assessment of outcomes, including any improvements in neurological function and overall health status.

The length of hospital stay and any rehabilitation needs are documented.

Who Can Join the Study?

The patient must have had an acute ischemic stroke in a specific area of the brain within the last 72 hours. An ischemic stroke happens when a blood vessel supplying blood to the brain is blocked.
The patient must show early signs of worsening or changes in their neurological condition, confirmed by a neurologist. This is defined by an increase of 3 or more points in the overall NIHSS score or a 2-point increase in movement or coordination scores. The NIHSS score is a tool used to measure the severity of a stroke.
The time between the early worsening of the condition and the start of the trial must be less than 6 hours.
The patient must be 18 years old or older.
Women who can have children must use contraception. This includes methods like an intra-uterine device, hormonal contraception that stops ovulation, female sterilization, having a partner who has had a vasectomy, or choosing not to have sex.
The patient must be covered by a health insurance system.

Who Cannot Join the Study?

Patients who have had a recent stroke. A stroke is when blood flow to a part of the brain is stopped or reduced, causing brain cells to die.
Patients who are not within the age range specified for the study.
Patients who are not able to give their own consent to participate in the study.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies or reactions to the study medication or similar drugs.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Ggytza Hfvzgovedmq Uigrzrmuaonbm Pvbyv Pxaonyutjze Es Nrvdntqtdxrb	Paris	France
Aadvrlydyp Pvlmkitr Hkfggnhy Dn Mghpbohls	Marseille	France
Csis Dg Nrnlb	Vandoeuvre Les Nancy	France
Cnxqsg Hipkknplzwe Reuzganh Dzddxufwhxxcdn	Angers	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Noradrenaline Tartrate

Norepinephrine is a medication used in this trial to help manage blood pressure. It is administered in a diluted form through a peripheral vein. The goal is to induce hypertension, which means raising the blood pressure, in patients who have experienced an acute progressive perforating artery stroke. This approach is being tested to see if it can improve the chances of patients regaining functional independence within 90 days after the stroke.

Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can lead to brain cells beginning to die within minutes. There are two main types of stroke: ischemic, caused by a blockage in an artery, and hemorrhagic, caused by a blood vessel leaking or bursting. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, and difficulty walking. The progression of a stroke can vary, with some individuals experiencing rapid onset of severe symptoms, while others may have more gradual changes. Immediate medical attention is crucial to minimize brain damage and potential complications.

Trial ID:

2023-508704-37-00

Protocol code:

CHUBX 2022/23

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Norepinephrine for Improving Outcomes in Patients with Acute Progressive Stroke

What is this study about?

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