RecruitingNAINTERVENTIONAL

Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization

This study is investigating a new treatment for chronic subdural hematoma (cSDH), which is a slow-growing collection of blood on the surface of the brain. Often, after surgery to drain this blood, it can return, requiring another operation. This research aims to see if adding an extra procedure can reduce the chances of the blood coming back. The extra procedure involves using a fine tube, threaded from the groin up to the head, to release tiny plastic particles that block small blood vessels that might contribute to the bleeding. This is done with the help of X-rays. Participants who have already had standard drainage surgery will either receive the usual care or this additional vessel-blocking procedure. The goal is to find a better way to keep cSDH from returning.

At a glance

Status

Recruiting

Phase

Sponsor

Unfallkrankenhaus Berlin

Enrolment target

154

Start

26 May 2022

Estimated completion

01 Oct 2025

Hematoma, Subdural, Chronic

What is this study about?

When you have a chronic subdural hematoma (cSDH), it means there's a slow build-up of blood between the brain and its outer protective layer. After surgery to drain this blood, it can sometimes come back, which is very frustrating and might mean more surgery.

This study is looking into whether an extra treatment, given alongside the standard surgery, can help stop the blood from returning. The idea is to block off some of the tiny blood vessels in the head that might be contributing to the problem. This is done using a special technique where a very thin tube is gently guided from a blood vessel in your groin all the way up to these small vessels in your head. Then, tiny plastic particles are released to block them. This procedure is monitored using X-rays and a special dye.

The researchers hope that by blocking these vessels, fewer people will experience the hematoma coming back after their initial operation. They want to see if this combined approach is more effective than just the standard surgery on its own. It's a way to try and give long-term relief from this condition.

Key takeaways

This study investigates a new treatment to prevent chronic subdural hematomas from returning.
It combines standard surgery with a procedure to block small blood vessels in the head.
Participants are randomly assigned to either receive standard care or standard care plus the new procedure.
The study includes optional genetic testing to understand recurrence risks.
Follow-up appointments are at one and three months after treatment.
The goal is to reduce the need for repeat surgeries caused by recurrent bleeds.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You must have recently had surgery to drain a chronic subdural hematoma, which involved making one or more small holes (burr holes) in your skull to remove the blood. You should also be able to understand what the study involves and agree to take part.

There are certain reasons why you might not be able to join. For example, if your subdural hematoma was treated without surgery, or if you had a different type of brain bleed, you wouldn't be eligible. Also, if you're pregnant, or if the special blood vessel procedure can't be done shortly after your initial surgery, you won't be able to participate. The study is very specific about the type of surgery you must have had.

Overall, the study is looking for adults who have had a very particular kind of surgery for a chronic subdural hematoma and are willing to have an additional procedure. Your doctor can help determine if you meet all the specific requirements.

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 surgery using one or more 'burr holes' to drain a chronic subdural hematoma?
Were you diagnosed with the hematoma using a CT or MRI scan?
Are you able to understand the study and give your permission to participate?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have your chronic subdural hematoma drained using the standard 'burr hole' surgery. Afterwards, you'll be randomly assigned to one of two groups, like flipping a coin. One group will receive the standard care, which means no additional procedure for the study. The other group will receive the additional procedure, which involves blocking small blood vessels in your head using tiny plastic particles. This extra procedure is done via a fine tube inserted into your groin, guided by X-rays. You won't know which group you are in until after the initial surgery.

There's also an option to agree to a genetic test, which involves giving a blood sample, to see if there's a link between your genes and the risk of the hematoma coming back. This is completely optional and won't affect your main participation in the study.

After your treatment, whether you have the standard care or the additional procedure, you'll have follow-up check-ups. These will typically happen one month and then three months after your procedure to see how you're recovering and if the hematoma has returned. The total duration of your active participation will be about three months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit of this study is that the additional procedure might reduce the chance of your chronic subdural hematoma returning, potentially meaning fewer repeat surgeries. However, there are also risks associated with the additional procedure, such as those linked to inserting a tube into blood vessels, the use of X-rays and contrast dye, and the chance of side effects from blocking small blood vessels, though these procedures are generally considered safe. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Unfallkrankenhaus Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is a chronic subdural hematoma?

It's a slow build-up of blood between your brain and its outer covering, often developing over weeks after a minor head injury.

What does 'burr hole trepanation' mean?

It's a common surgery where one or more small holes are made in your skull to drain the blood from the hematoma.

Will I feel the extra procedure to block blood vessels?

The procedure is done with local anaesthetic and often sedation, so you should be comfortable and generally won't feel pain during it.

Why is a genetic test offered?

It's optional and aims to see if certain genes are linked to whether the hematoma comes back, helping researchers understand the condition better.

What if the blood comes back even after the treatment?

The study aims to reduce the chance of recurrence, but standard medical care will still be available if the hematoma does return.

How to find out more

Johannes Lemcke, PD Dr. med.

johannes.lemcke@ukb.de 00493056813701 Official trial record

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