NanO2 in Large VessEL Occlusion Stroke (NOVEL)
This research trial, called NOVEL, is looking into a new treatment called NanO2 for a type of stroke caused by a blood clot blocking an artery in the brain. When this happens, the brain doesn't get enough oxygen, leading to damage. NanO2 is designed to carry extra oxygen to the brain, which might help protect brain tissue while doctors work to remove the clot. This could involve 'clot-busting' medicines or physical procedures to clear the blockage. The study will involve giving NanO2 as early as possible after a stroke and comparing brain scans. It's for people who have had a stroke within the last 9 hours, and will take place in several UK hospitals. Your involvement would last about 3 months.
At a glance
What is this study about?
This study, called NOVEL, is exploring a new way to help people who have had a stroke. Strokes happen when blood flow to part of the brain is interrupted. Often, this is because a blood clot blocks an artery, stopping oxygen and nutrients from reaching brain cells. Without oxygen, brain tissue quickly gets damaged.
The main idea behind this study is to see if a special treatment called NanO2 can protect brain cells from damage. NanO2 is designed to carry extra oxygen to the brain. Researchers hope that by giving the brain more oxygen, it might buy valuable time and keep brain cells alive for longer, especially while doctors are trying to unblock the artery.
This is particularly important because while treatments to clear blocked arteries are very effective, they can take some time to work. During this vital period, NanO2 might help reduce the amount of brain tissue that is permanently damaged. The study will look at how much brain tissue is affected before and after treatment with NanO2, using special brain scans.
Key takeaways
- The study is testing NanO2, a new treatment to help reduce brain damage in stroke.
- It's for strokes caused by blood clots that are treated very early.
- NanO2 aims to deliver extra oxygen to the brain after a clot.
- Participation involves hospital assessments and two follow-up phone calls.
- Your involvement would last around 3 months in total.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would need to be an adult (18 years or older) who has had an acute stroke caused by a blood clot, within the last nine hours. This time limit is really important, so if your stroke symptoms started while you were asleep, doctors would calculate the start time from the middle of the night.
Your doctors would also check some specific brain scans to make sure your stroke fits the study criteria. You would generally need to have been quite independent and able to manage most daily activities before your stroke. There are also some health conditions that would mean you couldn't join the study, such as severe kidney or liver problems, certain heart conditions, or pre-existing lung disease that requires oxygen. You also wouldn't be able to join if you are pregnant or breastfeeding, or have previously had a bad reaction to similar medicines.
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?
- Did your stroke symptoms start less than 9 hours ago?
- Was your stroke caused by a blood clot?
- Were you generally independent before your stroke?
- Do you have severe kidney or liver problems, or certain heart or lung conditions?
- Are you pregnant or breastfeeding?
What does participation involve?
If you join the study, you would receive the study treatment, NanO2, or a plain saltwater solution (as a comparison), given through a drip into your arm. Doctors would not know whether you received NanO2 or the saltwater. The study involves several checks and tests, mainly during the first five days while you are in hospital after your stroke. This would include brain scans and other medical assessments.
After you leave the hospital, there will be two follow-up phone calls. The first call will be about 30 days after you were discharged, and the second about 90 days after discharge. So, your total involvement in the study, from receiving the treatment to the final phone call, would last approximately 90 days (about three months).
Potential risks and benefits
Locations (1)
- NHS Greater Glasgow and ClydeVerified postcodeGlasgow, United Kingdom
Common questions
What type of stroke is this study for?
This study is for strokes caused by a blood clot blocking an artery in the brain.
What is NanO2?
NanO2 is a new treatment being studied that aims to carry extra oxygen to brain tissue to help protect it after a stroke.
How long does a stroke patient have to join the study?
You would need to join the study within 9 hours of your stroke symptoms starting.
How long will I be involved in the study?
Your involvement in the study will last about 90 days (3 months) in total, with most assessments in the first 5 days.
Will I know if I'm getting the new treatment?
Neither you nor your doctors will know if you are receiving NanO2 or the comparison saltwater solution.
How to find out more
Keith Muir
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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