AuthorisedTherapeutic confirmatory (Phase III)Interventional

FIBRINOGEN REPLACEMENT TO PREVENT INTRACRANIAL HAEMORRHAGE IN ISCHEMIC STROKE PATIENTS AFTER THROMBOLYSIS: A PILOT PROBE RANDOMIZED CONTROLLED TRIAL

This research study is for people who have had a type of stroke called an ischemic stroke (where a blood clot blocks blood flow to the brain). These patients often receive a powerful clot-busting medicine (rtPA). Sometimes, this medicine can reduce a protein in the blood called fibrinogen, which is important for clotting. When fibrinogen levels drop too low, it can increase the risk of bleeding, especially in the brain. This study aims to find out if giving extra fibrinogen as an injection can help prevent this dangerous bleeding in the brain. The researchers also want to see if this treatment improves patients' recovery and reduces other types of bleeding. It's a Phase III trial, meaning it's a later stage of research to confirm if the treatment works and is safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Unita Sanitaria Locale Di Bologna

Enrolment target

200

Start

04 Sep 2024

Ischemic stroke patients with secondary post-rtPA hypofibrinogenemia

What is this study about?

When someone has an ischemic stroke, it means a blood clot has blocked a blood vessel in their brain. To treat this, doctors often give a strong medicine called rtPA (also known as a 'clot-buster') to dissolve the clot and restore blood flow. While this medicine is very effective, it can sometimes lower the levels of a protein in the blood called fibrinogen. Fibrinogen is essential for forming blood clots to stop bleeding.

If fibrinogen levels become too low, it can increase the risk of bleeding, particularly a serious type of bleeding inside the brain, which is called an intracranial haemorrhage. This study is designed to investigate whether giving extra fibrinogen to patients after they've received the clot-busting medicine can help prevent these dangerous brain bleeds. The fibrinogen is given as an injection or drip into a vein.

The main goal of this study is to see if giving fibrinogen can reduce the number of serious bleeds in the brain. The researchers are also interested in whether it can reduce other types of bleeding and if it helps patients have a better recovery from their stroke. This is an important step to make stroke treatment even safer and more effective for future patients.

Key takeaways

This study investigates if fibrinogen can prevent brain bleeds after stroke treatment.
It's for people who've had an ischemic stroke and received a clot-busting medicine.
The main goal is to improve safety and recovery outcomes.
The treatment involves an injection or drip of fibrinogen.
Participation involves monitoring and follow-up over approximately 3 months.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part.

You might be able to join if you've recently had a type of stroke called an "ischemic stroke" (meaning a blood clot blocked a blood vessel in your brain). You would also need to have received a specific clot-busting medicine (called rtPA).

The doctors will also check your blood to see if your fibrinogen levels are low after receiving the clot-busting medicine. This is an important factor for joining the study.

Quick self-check

Are you 18 years or older?
Have you recently had an ischemic stroke (a stroke caused by a clot)?
Did you receive the clot-busting medicine called rtPA?
Have doctors told you that your fibrinogen levels are low after this treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have health checks and blood tests to make sure you are suitable. If you qualify and agree to join, you would be randomly assigned to receive either the fibrinogen treatment (called Riastap) or standard care, or a placebo (an inactive substance that looks like the treatment but has no medicine in it). You wouldn't know which group you are in, and neither would your doctors.

The fibrinogen treatment (or placebo) would be given through a drip into your arm. Doctors would closely monitor you for any bleeding or other side effects. You would have your health checked regularly, including blood tests and assessments of your stroke recovery. This would involve checking your abilities and how you are feeling at 7 days and then again at 3 months after starting the study. The total time for follow-up for the study would be around 3 months.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A possible benefit of this study is that receiving fibrinogen might reduce your risk of serious bleeding in the brain after your stroke treatment, which could lead to a better recovery. However, we don't know for sure if it will help, as that's what the study is trying to find out. Potential risks could include side effects from the fibrinogen treatment itself, such as allergic reactions or other clotting issues, although these are closely monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is fibrinogen and why is it important?

Fibrinogen is a protein in your blood that helps it clot. It's crucial for stopping bleeding.

What is an ischemic stroke?

This is a type of stroke where a blood clot blocks blood flow to part of your brain.

What does 'randomised' mean in a study?

It means you are randomly assigned to a treatment group, like flipping a coin, to make the study fair.

What is a 'Phase III' trial?

This is a later stage of research where doctors want to confirm if a new treatment works, is safe, and is better than existing options.

Will I know if I'm getting the active treatment?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're getting the fibrinogen or a placebo.