RecruitingPHASE2, PHASE3INTERVENTIONAL

Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.

This study is investigating a common condition called chronic subdural hematoma, which is a collection of blood on the surface of the brain, most often affecting older people. Sometimes, these hematomas can reappear even after treatment. Researchers are exploring a new idea: could a mild, hidden infection be causing these hematomas, particularly when they come back? They've previously found signs of a low-level infection in some recurring cases. This new study aims to see if such an infection is also present in new cases. It will test if an antibiotic (amoxicillin + clavulanic acid) can help by targeting these potential infections, compared to a dummy pill (placebo). This research could lead to better ways to treat and prevent these hematomas.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

University of Rostock

Enrolment target

164

Start

01 Sep 2024

Estimated completion

30 Jun 2027

Chronic Subdural Hematomas

What is this study about?

This research is looking into a condition called a chronic subdural hematoma. This is essentially a collection of old blood that builds up slowly on the surface of your brain, under its outer covering. It's quite common, particularly in older people, and can cause significant health problems, even after treatment. Sometimes, these blood collections can come back, which is called a recurrence, and doctors don't fully understand why this happens.

The scientists behind this study have a new idea. They recently found signs of a very mild, sometimes hidden, infection in about 30% of cases where the blood collection came back. This was a surprising discovery, as infections hadn't previously been considered a major cause in this area. This finding made them wonder: could this mild infection actually be present from the start in people who develop a chronic subdural hematoma, not just when it comes back?

So, this study aims to explore this further. They want to see if this type of low-level infection is present in people with new chronic subdural hematomas. They will also be testing whether giving an antibiotic (a medicine called amoxicillin + clavulanic acid) might help by treating these potential infections, compared to giving a placebo, which is a dummy pill with no medicine in it. The hope is that understanding this better could lead to new and more effective ways to treat and perhaps even prevent these conditions.

Key takeaways

A study investigating if hidden infections cause blood collections around the brain (chronic subdural hematomas).
It aims to understand why these blood collections sometimes return.
Compares an antibiotic to a dummy pill to see if it helps.
Recruiting adults undergoing surgery for a new chronic subdural hematoma.
Could lead to new treatments to prevent recurrence.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older and be undergoing surgery for a chronic subdural hematoma.

However, you will not be able to join if you have recently taken or are currently taking antibiotics, or if you have any other ongoing infection. You also won't be able to join if you've already had a chronic subdural hematoma that has come back, or if your hematoma is being treated without surgery.

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?
Are you having surgery for a chronic subdural hematoma?
Have you *not* taken antibiotics recently or currently?
Do you *not* have another active infection?
Is this your first chronic subdural hematoma (it hasn't come back before)?
Is your chronic subdural hematoma being treated with surgery, not just observation?

Answer every question to see your result.

What does participation involve?

This section is not available based on the provided brief summary and detailed description. The provided information only details the interventions (medication vs. placebo), but does not specify the number of visits, assessments, how the medication will be administered, how long the follow-up will last, or the total duration of participation.

Potential risks and benefits

Taking part in this study could potentially help us understand more about chronic subdural hematomas and lead to better treatments in the future. If the antibiotic is effective, it might reduce the chance of the blood collection coming back. However, like all medications, the antibiotic might have side effects, and some people will receive a dummy pill meaning they won't get the potential benefit of the antibiotic. You will be closely monitored by medical staff throughout the study. Remember, joining is entirely your choice, and you are free to leave the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

UnIversity Medical Center Rostock
Verified postcode
Rostock, Germany· Recruiting

Common questions

What is a chronic subdural hematoma?

It's a slow build-up of old blood on the surface of the brain, usually after a minor head bump, particularly affecting older people.

Why is this study important?

Doctors don't fully understand why these blood collections sometimes come back. This study explores a new idea: that a hidden infection might be a cause, which could lead to better treatments.

What is 'amoxicillin + clavulanic acid'?

It's a common antibiotic medication used to treat bacterial infections. In this study, it's being tested to see if it helps with chronic subdural hematomas.

What is a 'placebo'?

A placebo is a dummy pill that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the actual medicine fairly.

Will I know if I'm getting the antibiotic or the placebo?

No, this study is 'blinded,' meaning neither you nor your doctor will know whether you are receiving the antibiotic or the placebo. This helps ensure the results are fair and unbiased.

How to find out more

Daniel PD Dr.med.habil. Dubinski, MD MSc

daniel.dubinski@med.uni-rostock.de +49 381 494 6439 Official trial record

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