Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization
This study is investigating a new treatment for chronic subdural hematomas (CSH), which are blood clots on the brain. These clots are becoming more common, especially in older people taking blood thinners. While surgery can treat them, they often return. This study looks at using a special 'glue' called cyanoacrylate embolization to block small blood vessels in the brain's lining that are thought to make the CSH grow or bleed again. Researchers believe this method, used alongside or instead of standard surgery, could reduce how often CSH comes back. The study compares patients receiving this new treatment with those getting standard care to see if it makes a difference.
At a glance
What is this study about?
This study is about a health condition called chronic subdural hematoma (CSH). This happens when blood collects slowly on the surface of your brain, underneath the skull. It's becoming more common, especially in older people or those taking medicines that thin the blood. While doctors can often treat CSH with surgery, these blood collections sometimes come back.
The study aims to find out if a new treatment can help reduce the chances of CSH returning. This new treatment involves a procedure called embolization, where doctors use a special medical 'glue' (called cyanoacrylate) to block tiny blood vessels that are thought to feed the blood collection and make it grow. The idea is that by blocking these vessels, the CSH will be less likely to come back. This treatment might be used on its own for less severe cases or alongside regular surgery for more serious ones.
Researchers want to see if this new approach, either with or without surgery, is better than current standard treatments at preventing the CSH from recurring. They will compare how well patients do with the new treatment versus those receiving standard care. They chose this particular 'glue' because it's simpler to use and potentially less uncomfortable than other options.
Key takeaways
- This study is testing a new way to treat blood clots on the brain (CSH).
- It uses a medical 'glue' to block tiny blood vessels that feed the clot.
- The goal is to stop the blood clot from coming back after treatment.
- This new treatment might be used with or instead of standard surgery.
- Participants will be assessed at 2 and 6 months to check their progress.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a chronic subdural hematoma (CSH) that is at least 10mm thick and located in a specific area on your brain. You also need to have health insurance.
There are certain reasons why you might not be able to join. These include having severe kidney problems or allergies that would make the procedure unsafe. Also, if you already have significant long-term health issues that severely affect your daily life, or if doctors expect you to live less than six months due to another illness, you won't be able to participate.
Pregnant or breastfeeding women, as well as people under legal protection or who cannot give their informed consent, cannot take part in this study.
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?
- Do you have a chronic subdural hematoma (CSH) confirmed by a scan?
- Do you have health insurance?
- Are you able to provide your own consent?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you take part in this study, you will either receive the new embolization treatment alongside standard care (like surgery or observation), or you will receive standard care alone. The decision on whether you need surgery or not will be made by your neurosurgeon. If you are in the group getting the new treatment, doctors will perform the embolization procedure, potentially using a mild sedation or local numbing medicine. You will be assessed at about 2 months and again at about 6 months after treatment to check your recovery and the volume of the CSH. The assessments may include questionnaires about your daily life and check-ups on the size of the blood collection.
Potential risks and benefits
Locations (11)
- CHU Amiens-PicardieVerified postcodeAmiens, France· Terminated
- CHU BrestVerified postcodeBrest, France· Recruiting
- CHU CaenVerified postcodeCaen, France· Terminated
- Hôpital Henri MondorVerified postcodeCréteil, France· Recruiting
- CHU NantesVerified postcodeNantes, France· Recruiting
- CHU NiceVerified postcodeNice, France· Recruiting
- Hôpital Pitié SalpêtrièreVerified postcodeParis, France· Recruiting
- Hôpital Fondation RothschildVerified postcodeParis, France· Recruiting
- CHU ToursVerified postcodeTours, France· Terminated
- CHU BordeauxVerified postcodeBordeaux, France· Recruiting
- CHU NancyVerified postcodeNancy, France· Recruiting
Common questions
What is a chronic subdural hematoma (CSH)?
It's a slow collection of blood on the surface of the brain, under the skull, which can cause symptoms.
What is embolization?
It's a procedure where a doctor blocks blood vessels, in this case, using a special medical 'glue' to stop blood flow to certain areas.
Will I definitely get the new treatment?
You will be randomly assigned to either receive the new treatment plus standard care, or standard care only. Not everyone will get the new treatment.
How long will the study last for me?
Your progress will be checked at around 2 months and again at around 6 months after your treatment.
What if I change my mind about participating?
You can leave the study at any time without it affecting your medical care.
How to find out more
jean-Christophe GENTRIC, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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