Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Impact on gastric emptying measured by antral gastric ultrasound of erythromycin administration in stroke patients with indication for mechanical thrombectomy.

This study is for adults who have had a type of stroke and need a special procedure to remove a blood clot. Before the procedure, doctors use a scan to check if the patient's stomach is full. If it is, they might be given a medicine called erythromycin. The main goal is to see if this medicine helps empty the stomach. Emptying the stomach is important to reduce risks during the procedure, like accidentally breathing fluid into the lungs. We will compare stomach scans before and after the procedure to see if the medicine made a difference.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital Foch

Enrolment target

Start

09 Feb 2024

What is this study about?

Imagine you or someone you know has had a stroke, and doctors need to perform a procedure to remove a clot. This procedure, called a thrombectomy, can be very important. Before such procedures, doctors are always concerned about whether a patient's stomach is full. If the stomach is full, there's a small risk that stomach contents could accidentally be breathed into the lungs during the procedure, which could cause serious problems.

This study is looking at a medicine called erythromycin. You might know it as an antibiotic, but it can also help the stomach empty its contents more quickly. The researchers want to see if giving erythromycin to stroke patients with a full stomach, just before their clot removal procedure, can help speed up stomach emptying. They will use a special ultrasound scan to measure how much is in the stomach both before and after the procedure.

By understanding if erythromycin helps empty the stomach in these patients, doctors hope to improve safety during the clot removal procedure. This is a "Phase IV" study, which means the medicine is already approved for other uses, and doctors are now looking at its effect in a new specific situation.

Key takeaways

Study is for stroke patients needing clot removal.
Checks if erythromycin helps empty the stomach.
A full stomach can be a risk during procedures.
Uses ultrasound scans to measure stomach contents.
Participation will happen alongside your usual stroke care.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. To be considered, you must have recently had a specific type of stroke and doctors must have decided you need a procedure to remove a blood clot.

Before you can officially join the study, doctors will first do an ultrasound scan of your stomach. This scan helps them see how much is in there. You will only be able to take part if your stomach scan shows it is quite full (they measure a specific area of the stomach that is larger than 340mm²). If your stomach isn't full enough according to their measurements, you won't be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a type of stroke?
Do doctors say you need a clot removal procedure?
Did your stomach ultrasound scan show your stomach was full?

Answer every question to see your result.

What does participation involve?

If you are eligible, you will have an ultrasound scan of your stomach taken before the clot removal procedure. If this scan shows your stomach is full, you might be given the study medicine, erythromycin, typically through a drip. Another scan of your stomach will be done after the procedure to see if the medicine had an effect. Doctors will also check for any common issues that can happen during procedures like this, such as changes in blood pressure or oxygen levels. During your hospital stay, doctors will note if you need oxygen or if you are transferred to intensive care. They will also keep an eye out for any side effects from the erythromycin. The study measures will happen alongside your standard care for stroke and its duration will depend on your hospital stay.

Potential risks and benefits

Taking part in this study may offer a potential benefit by helping doctors understand how to make procedures safer for stroke patients. While erythromycin is a commonly used medicine, like all medicines, it can have side effects. Doctors will carefully monitor you for any problems related to the medicine or the procedure itself. Remember, participation is completely voluntary; you can choose to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a stroke?

A stroke happens when blood flow to part of your brain is stopped or reduced, which can damage brain cells.

What is thrombectomy?

Thrombectomy is a procedure where doctors carefully remove a blood clot from an artery in the brain, often using a special device.

Why is it important if my stomach is full?

If your stomach is full during a procedure, there's a small risk of stomach contents accidentally entering the lungs, which can cause serious breathing problems.

What is erythromycin?

Erythromycin is a medicine usually used to treat infections, but it can also help the stomach empty its contents more quickly.

Will I definitely get erythromycin if I join?

If your stomach scan shows it's full, you might be given erythromycin as part of the study, but it's not guaranteed for everyone if another group is being compared.