AuthorisedTherapeutic exploratory (Phase II)Interventional

Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration (ReSCInD)

This study, called ReSCInD, is investigating a new way to help people who have had a type of stroke called an ischemic stroke. This happens when a blood clot blocks blood flow to the brain, causing damage. The study is testing a drug called DNase, which is given through a drip, to see if it can reduce inflammation (swelling and irritation) in the body. Researchers believe that reducing this inflammation might help to limit brain damage and improve recovery. They are particularly interested in seeing if DNase can lower levels of a specific chemical called IL-1β in the blood, which is a marker of inflammation, within 24 hours of the stroke.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Klinikum der Universitaet Muenchen AöR

Enrolment target

Start

31 Oct 2024

Reduction of SystemiC Inflammation after ischemic stroke by intravenous DNase administration

What is this study about?

When someone has a stroke, especially an ischemic stroke where a blood clot blocks blood flow to the brain, the body often reacts by producing a lot of inflammation. This inflammation, or swelling and irritation, can sometimes cause even more damage to the brain after the initial stroke. Doctors and researchers are always looking for ways to reduce this inflammation, hoping it could lead to better recovery for patients.

This particular study, named ReSCInD, is a Phase II trial. This means it's one of the earlier steps in testing a new treatment, focusing on whether the treatment is safe and if it shows some promising effects. The researchers are looking at a drug called DNase. This drug is already used for other conditions, but this study is exploring if giving it into a vein (intravenously) after a stroke could reduce the inflammation.

Specifically, the main thing the researchers want to find out is if DNase can lower the levels of a chemical called IL-1β in the blood. IL-1β is a key signal chemical that plays a big role in causing inflammation in the body. By measuring its levels in the blood within 24 hours after a stroke, they hope to see if DNase makes a difference. They will also look at other effects of the drug to get a broader picture of its potential benefits.

Key takeaways

The study aims to reduce brain inflammation after a stroke.
It uses a drug called DNase, given through a drip.
Researchers will measure a chemical called IL-1β in the blood.
Participation involves potential new treatment and regular monitoring.
It's a step towards finding better stroke treatments.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you would need to be at least 18 years old. Both men and women are welcome to participate. The study is looking for people who have recently had a specific type of stroke, an ischemic stroke.

There might be other health conditions or medications that could prevent someone from joining, as the researchers need to make sure it's safe for everyone involved. For example, if you have certain existing health problems or are taking particular medicines, you might not be suitable for the study. These details would be checked carefully by the study team.

It's important to remember that all these rules are in place to keep participants safe and to make sure the study can give clear answers about the treatment being tested.

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 an ischemic stroke?
Are you willing to receive medication through a drip?
Are you comfortable with blood tests?
Have you discussed your current health conditions and medications with the study team?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you're a good fit. If eligible, you would then be randomly assigned to one of two groups. One group would receive the study drug (DNase) through a drip into a vein, and the other group would receive a plain salt solution (which looks exactly the same) also through a drip. This is done to compare the effects of the actual drug against a placebo.

You would have blood tests to measure your IL-1β levels and other markers at different times, especially within 24 hours and then again after 3 days. The study team would also monitor your health closely throughout your participation. The total duration of your active involvement in the study would depend on the specific schedule, but it would involve initial treatment and follow-up assessments.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. While there's no guarantee you will personally benefit, you might receive a new treatment that could help reduce inflammation after your stroke. Your participation will definitely help researchers learn more about stroke recovery, which could benefit many people in the future. As with any medication, there could be side effects or risks associated with the DNase drug or the procedures involved, such as blood tests or intravenous drips. These would all be explained to you in detail by the study team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Germany

Common questions

What is an ischemic stroke?

An ischemic stroke happens when a blood clot blocks an artery that supplies blood to the brain, cutting off oxygen and causing brain cells to die.

What is DNase?

DNase is a medication that helps break down DNA. It's already used for some conditions, and this study is exploring if it can help reduce inflammation after a stroke.

What does 'intravenous administration' mean?

It means the medication is given directly into a vein, usually in your arm, through a drip.

What is IL-1β?

IL-1β is a natural chemical in your body that plays a big role in causing inflammation. High levels can indicate a strong inflammatory response.

What is a Phase II trial?

A Phase II trial is an early stage of testing a new treatment. It looks at whether the treatment is safe and if it shows some promising signs of working.