RecruitingOBSERVATIONAL

Immunoadsorption Versus Plasma Exchange for Treatment of Guillain-Barré Syndrome (GBS)

This study is comparing two important treatments for a condition called Guillain-Barré Syndrome (GBS). GBS is a rare but serious condition where your immune system attacks your nerves. The two treatments being looked at here are called immunoadsorption and plasma exchange. Both aim to remove harmful substances from your blood that might be causing the nerve damage in GBS. This study is an 'observational' one, which means researchers will follow people who are already receiving one of these treatments as part of their care. They want to understand how safe each treatment is and how well it helps people recover from GBS. It's for adults aged 18 and over who have been diagnosed with GBS.

At a glance

Status

Recruiting

Sponsor

University of Ulm

Enrolment target

Start

28 Apr 2021

Estimated completion

01 Sep 2027

GBS

What is this study about?

This study is designed to help doctors understand the best ways to treat Guillain-Barré Syndrome, often shortened to GBS. GBS is a rare condition where your body's own defence system, called the immune system, mistakenly attacks your nerves. This can cause muscle weakness, numbness, and sometimes paralysis. Receiving treatment early is very important.

The study is comparing two well-known treatments for GBS: immunoadsorption and plasma exchange. Both treatments work by cleaning your blood to remove harmful antibodies that are believed to cause nerve damage in GBS. Immunoadsorption uses special filters to specifically target and remove these antibodies, while plasma exchange involves removing a part of your blood called plasma and replacing it with healthy fluid. Doctors want to see how these two treatments compare in terms of their safety – meaning how few side effects they cause – and how well they help people recover from GBS symptoms.

This is an "observational" study. This means that people in the study will be receiving either immunoadsorption or plasma exchange as part of their usual medical care for GBS, as decided by their doctors. The researchers will then carefully observe and collect information about how these treatments work for each group. The goal is to gather more reliable information about which treatment might be more beneficial or have fewer risks for people living with GBS in a real-world setting.

Key takeaways

This study compares two standard GBS treatments: immunoadsorption and plasma exchange.
It aims to understand which treatment is safer and more effective.
You must have a GBS diagnosis and be aged 18 or over to be considered.
It's an observational study, so you receive standard care; no new treatments.
Your individual medical care decisions are made by your doctors.
Participation helps improve care for future GBS patients.

Who may be eligible?

To take part in this study, you need to meet certain requirements. Firstly, you must have been officially diagnosed with Guillain-Barré Syndrome (GBS) by a doctor, following specific medical guidelines.

Secondly, you must be an adult, aged 18 years or older. There is no upper age limit, so adults of all ages can be considered. The study is open to both men and women.

However, there are also some reasons why you might not be able to participate. If you have clear signs of a serious infection, either from your symptoms or from blood test results, you wouldn't be able to join. Also, if you've taken a type of blood pressure medication called an "ACE inhibitor" within one week before starting treatment, you would be excluded. Finally, if your doctor believes there are other medical reasons or conditions that would make either immunoadsorption or plasma exchange unsafe for you, you also 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 been diagnosed with Guillain-Barré Syndrome (GBS)?
Are you 18 years old or older?
Do you have any signs of a serious infection (like a high fever or specific blood test results)? (If yes, you might not be able to join.)
Have you taken any ACE inhibitor blood pressure medication in the last week? (If yes, you might not be able to join.)
Are there any other serious medical reasons why your doctor might advise against immunoadsorption or plasma exchange?

Answer every question to see your result.

What does participation involve?

As this is an observational study, taking part would primarily involve researchers collecting information about your usual medical care for GBS. You would receive either immunoadsorption or plasma exchange, as decided by your doctors, based on what they believe is best for you.

Researchers would then collect information from your medical records regarding your GBS diagnosis, the treatment you receive, and how you respond to it. This would include details about your symptoms, any side effects, and how your condition changes over time. You wouldn't be asked to take any new or experimental medications, nor would you undergo extra tests or visits beyond what is already part of your standard care for GBS. The exact duration of observation would depend on your treatment plan and recovery, but it aligns with the typical follow-up for GBS patients.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of which GBS treatment might be most effective and safe for future patients. As an observational study, you would receive standard, approved treatments, so you wouldn't be exposed to unknown risks of experimental therapies. However, both immunoadsorption and plasma exchange, like any medical procedure, carry potential risks and side effects that your doctors would discuss with you, such as reactions to the procedures themselves or issues with access points. You are always free to withdraw from participating in the study's data collection at any time, without affecting your care.

Locations (1)

Department of Neurology, University of Ulm
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is Guillain-Barré Syndrome (GBS)?

GBS is a rare condition where your body's immune system mistakenly attacks your nerves, leading to weakness and numbness, often starting in your feet and hands.

What is the difference between immunoadsorption and plasma exchange?

Both treatments clean your blood to remove harmful substances. Immunoadsorption targets specific substances, while plasma exchange replaces a part of your blood called plasma with a healthy fluid.

Will I receive a new medicine if I join this study?

No, this study observes standard GBS treatments. You will receive either immunoadsorption or plasma exchange, which are established treatments for GBS, as determined by your doctor.

Do I need to visit the hospital more often if I join this study?

No, as this is an observational study, it won't require extra hospital visits or tests beyond your usual medical care for GBS.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study's data collection at any time, and this will not affect your medical care.

How to find out more

Johannes Dorst, Prof

johannes.dorst@uni-ulm.de +49 731 177 5285 Official trial record

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