Active not recruitingNAINTERVENTIONAL

Head COOLing in IscHemic Stroke Patients Undergoing EndovAscular Thrombectomy: a Feasibility and Safety StuDy

This study is exploring a new technique called head cooling for patients experiencing a specific type of stroke when they are also undergoing a procedure to remove a clot. The main goal is to find out if this head cooling method is safe to use and if it can be successfully applied during the treatment. By gently lowering the head temperature, doctors hope to protect the brain from further damage after a stroke. This is an early-stage study, meaning it's one of the first times this specific cooling method is being tested in this situation. It's an important step to see if this approach could eventually help improve recovery for stroke patients. It's not comparing it to other treatments, but just observing how it works.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Calgary

Enrolment target

Start

28 Jul 2024

Estimated completion

24 Feb 2025

Stroke, Acute

What is this study about?

This study is looking into a new idea to help people who have had a type of stroke called an ischaemic stroke. This kind of stroke happens when a blood clot blocks blood flow to the brain. Often, doctors can remove these clots using a special procedure called endovascular thrombectomy.

The study wants to see if gently cooling a patient's head during this clot-removal procedure is safe and practical. The thought is that lowering the brain's temperature might help protect it from damage as a result of the stroke. Think of it like putting an injury on ice to reduce swelling – in this case, it's about protecting brain cells.

This is a "feasibility and safety" study, which means it's an early step. Researchers want to make sure that the head cooling method can be done safely and without problems while the clot-removal procedure is happening. If it proves safe and possible, it could open the door for more research into whether this technique can improve recovery for stroke patients in the future.

Key takeaways

The study explores head cooling during stroke treatment.
It aims to check if head cooling is safe and possible.
The goal is to protect the brain after a stroke.
It's for adults with a specific type of stroke getting clot removal.
Your health will be closely monitored if you take part.

Who may be eligible?

To be able to join this study, you would need to be an adult (18 years or older) who has recently had a specific type of stroke in the front part of your brain. You would also need to be planned to have a procedure to remove the blood clot causing your stroke.

However, there are some reasons why you might not be able to take part. For example, if your body temperature is already very low, or if you have certain heart problems or blood conditions that could make cooling unsafe. Also, if you have skin problems on your head that would make it hard to use the cooling cap, or if you have certain conditions where cold can make your blood vessels spasm, you wouldn't be able to join. Finally, if you know you won't be able to come back for follow-up appointments after three months (for instance, if you live far away), you might not be eligible.

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 stroke in the front part of your brain?
Are you planned to have a procedure to remove a blood clot (thrombectomy)?
Do you not have any major heart problems, blood conditions, or skin issues on your head?
Are you able to attend follow-up appointments for three months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have a special cooling cap placed on your head during your stroke treatment (endovascular thrombectomy). The cooling cap is designed to gently lower the temperature of your head. The doctors and nurses would carefully monitor you throughout the procedure. After your stroke treatment, there will be follow-up appointments to check on your recovery and overall health. These checks will continue for up to three months after your stroke. This study doesn't involve any new medication, only the head cooling device.

Potential risks and benefits

Potential benefits of taking part in this study are not guaranteed, but the research aims to see if head cooling could help protect the brain during stroke treatment. You might not directly benefit, but your involvement could help doctors learn more and potentially improve future stroke care. As with any medical procedure, there are potential risks, though the study is focused on safety. These might include discomfort from the cooling cap or potential effects of lowering body temperature, which will be closely monitored by medical staff. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

Foothills Medical Center
Verified postcode
Calgary, Canada
Te Whatu Ora Te Toka Tumai Auckland
Verified postcode
Auckland, New Zealand

Common questions

What is an ischaemic stroke?

An ischaemic stroke happens when a blood clot blocks blood flow to a part of your brain, damaging brain cells.

What is endovascular thrombectomy?

This is a procedure where doctors use special tools inserted into a blood vessel to remove a blood clot from the brain.

What does 'head cooling' mean?

It means using a special cap placed on your head to gently lower the temperature of your brain during the stroke treatment.

Why are they doing this study?

They want to find out if cooling the head during stroke treatment is safe and practical, hoping it might help protect the brain.

Will I get 'cold' all over?

The cooling is focused on your head. Your body temperature will be carefully monitored, and the aim is not to make your whole body dangerously cold.