RecruitingPHASE3INTERVENTIONAL

Combination of Hypothermia and Thrombectomy in Acute Stroke

This research is investigating a new way to treat a serious type of stroke, called an ischaemic stroke, where a blood clot blocks a major blood vessel in the brain. Even with standard treatments like removing the clot, many patients don't fully recover. This study aims to see if adding mild cooling (hypothermia) to 35°C shortly after the stroke, and for a few hours after clot removal, can improve recovery significantly. The cooling is done using a special non-invasive device through the nose and then surface cooling pads. Researchers will compare patients who receive this cooling plus standard care, to those who only receive standard care, to find out if the cooled group has better outcomes after three months without more complications.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Freiburg

Enrolment target

400

Start

07 Jul 2024

Estimated completion

18 Jun 2026

Ischemic Stroke Large Vessel Occlusion Endovascular Treatment

What is this study about?

This study, called COTTIS-2, is looking at how to improve outcomes for people who have had a very serious type of stroke called an acute ischaemic stroke. This happens when a major blood vessel in the brain gets blocked by a blood clot, stopping blood flow. Even though doctors can often remove these clots with a procedure called endovascular treatment (EVT), many patients still don't make a full recovery.

The idea behind this study is that cooling the body to a slightly lower temperature (35°C, which is called mild hypothermia) might protect the brain from damage during and after the stroke. Think of it like keeping something delicate cool to prevent it from spoiling. Previous studies on cooling for stroke haven't always worked, often because the cooling was too deep, started too late, or patients couldn't tolerate it well. This new study uses an improved cooling method that starts quickly and is aimed at a target temperature that was found to be safe and achievable in a previous pilot study.

Researchers want to find out if this additional cooling, given soon after the stroke and continuing for six hours after the clot is removed, can lead to a better recovery for patients after three months, without causing extra problems. They will compare two groups of patients: one group will receive the cooling treatment alongside standard care (which includes medications and the clot removal procedure), and another group will receive only the standard care. This comparison will help determine if cooling really makes a difference.

Key takeaways

Tests if mild cooling improves stroke recovery.
Aims to protect the brain after a clot is removed.
Uses a special nasal cooling device followed by surface cooling.
Compares cooled patients to those receiving standard care.
Looks for better recovery after three months without more complications.
Aims for 35°C (mild hypothermia) for six hours post-clot removal.

Who may be eligible?

To be considered for this study, you would generally need to have had a specific type of stroke called an acute ischaemic stroke, where a main artery in the brain is blocked. Your ability to live independently before the stroke (meaning you didn't need much help with daily tasks) is also important. The stroke must be severe enough to cause certain symptoms and be suitable for treatment to remove the clot.

There are also some specific timings involved. For example, how long it's been since you were last seen well, and certain scans of your brain, will help doctors decide if you might be suitable for the study's main treatment. Whether you've received a clot-busting drug (intravenous thrombolysis) doesn't stop you from being included.

However, you wouldn't be able to join if you have certain other serious health issues, such as severe bleeding problems, recent head injuries or brain surgery, severe infections, or if you're pregnant. Also, if there's a physical problem that prevents the special cooling device from being inserted through your nose, you wouldn't be able to take part.

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.

Have you recently had a stroke caused by a blood clot in a large brain vessel?
Were you living independently before your stroke, needing little to no daily help?
Has it been less than 24 hours since your stroke symptoms started or you were last seen well?
Do you have a blockage in a major brain artery that doctors plan to treat?
Are you able to have the nasal cooling device inserted without problems?
Are you able to participate in a 3-month follow-up for your recovery?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be immediately cooled using a special device inserted through your nose, and then with surface cooling pads, to reach and maintain a body temperature of 35°C. This cooling would continue for six hours after the blood clot in your brain is successfully removed, then your body would be slowly warmed back to normal temperature. You would also receive all the usual, best medical care for your stroke, including the procedure to remove the clot and potentially clot-busting medication.

Researchers will regularly check on your health and recovery over a period of three months. This will involve assessments to see how well you are recovering from your stroke and to monitor for any side effects or complications. The total duration of active cooling is relatively short (about six hours plus slow rewarming), but your overall participation for follow-up will be three months.

Potential risks and benefits

The potential benefit of taking part is that the cooling treatment might lead to a better recovery from your stroke than with standard care alone. The previous pilot study suggested this specific cooling method is safe and well-tolerated. However, as with any medical treatment, there are potential risks, though in the pilot study, side effects during cooling were not serious. You will be closely monitored by medical staff throughout the process. It's very important to remember that you are free to withdraw from the study at any time, for any reason, and this will not affect the quality of your medical care.

Locations (1)

University of Freiburg, Department of Neurology
Verified postcode
Freiburg im Breisgau, Germany· Recruiting

Common questions

What is an ischaemic stroke?

It's a type of stroke caused by a blood clot blocking a blood vessel to the brain, stopping blood flow and damaging brain cells.

What does 'hypothermia' mean in this study?

It means gently cooling your body down to 35°C, just slightly below normal body temperature, to help protect your brain.

How is the cooling done?

It starts rapidly using a special device through your nose (like a thin tube), then continues with cooling pads placed on your skin.

Will I experience shivering?

In the previous study, patients were sedated, which helped manage discomfort like shivering during the cooling process.

What happens after the cooling?

After six hours of cooling, your body will be slowly warmed back up to its normal temperature, and you'll continue with your usual stroke recovery care.

How to find out more

Juergen Bardutzky, Prof.

juergen.bardutzky@uniklinik-freiburg.de +49-15237729739 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.