Not yet recruitingNAINTERVENTIONAL

Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA/NETs in Subjects With Pancreatitis

This study is investigating a new treatment for people with severe acute pancreatitis, a serious condition where the pancreas becomes inflamed. Researchers are looking at a device called NucleoCapture, which works by removing certain harmful substances and waste products, like 'cell-free DNA' and 'NETs', from the blood. These substances are thought to make pancreatitis worse. The study wants to find out if this device is safe, can be used easily, and if it helps reduce these harmful substances. Patients will either receive standard hospital care or standard care plus treatment with the NucleoCapture device. The goal is to see if this new treatment can improve outcomes for patients with pancreatitis, especially if they are also experiencing organ problems.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Enrolment target

Start

01 Dec 2025

Estimated completion

01 Apr 2027

Acute Pancreatitis Organ Failure, Multiple

What is this study about?

Imagine your pancreas, an organ that helps with digestion and blood sugar, suddenly becomes very inflamed. This is called acute pancreatitis. It can be quite serious, sometimes leading to other organs like your lungs or kidneys struggling to work properly. When this happens, your body can release certain harmful substances, like tiny bits of genetic material (called cell-free DNA) and sticky webs from white blood cells (called NETs). Scientists believe these substances can make the inflammation and organ problems much worse.

This study is testing a new device called NucleoCapture. Think of it like a special filter for your blood. The device is designed to remove these harmful substances (cfDNA and NETs) from your blood outside your body, similar to how kidney dialysis works. The main aim is to see if this process is safe and easy to perform, and if it actually reduces the level of these bad substances in your blood. By doing this, researchers hope to discover if the NucleoCapture device could help people with severe pancreatitis recover better and prevent complications.

The study will involve patients who have severe acute pancreatitis and are in the intensive care unit. Some patients will receive the usual hospital care, while others will receive the usual care *plus* treatment with the NucleoCapture device. This will help doctors compare the two groups and understand if the new treatment makes a positive difference. It's an important step in finding better ways to help those affected by this serious condition.

Key takeaways

The study tests a new 'blood filtering' device (NucleoCapture) for severe pancreatitis.
It aims to remove harmful substances (cfDNA/NETs) from the blood.
Patients receive either standard care or standard care + NucleoCapture.
The main goal is to check for safety, ease of use, and treatment effect.
Participation involves daily treatments for 3 days and health checks over several weeks.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with acute pancreatitis. You would be considered if your pancreatitis is causing problems with your breathing, heart, or kidneys, and if these issues are still present after initial hospital treatment but haven't been going on for too long (less than 3 days). All types of pancreatitis causes are welcome.

There are also some reasons why you might not be able to join. For example, if you are already having other special blood filtering treatments, or if you have very severe multiple organ failure, including specific severe heart or blood clotting problems. The study also can't include people with certain existing liver diseases or active bleeding. If your blood volume is calculated to be very high, that would also exclude you. The medical team will check all these details carefully to make sure the study is right for you.

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 been diagnosed with acute pancreatitis?
Is your pancreatitis causing severe issues with your breathing, heart, or kidneys?
Are these organ problems still present after initial fluid treatment, but started less than 3 days ago?
Do you have severe existing medical conditions like liver cirrhosis or active bleeding?
Are you currently having other intense blood filtering treatments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the standard care given in the hospital for pancreatitis, or you will receive standard care plus treatment with the NucleoCapture device. If you are in the NucleoCapture group, you will have one treatment session each day for the first three days. Each session involves your blood being gently filtered by the device for up to six hours. If a session doesn't filter enough blood, it might be repeated the next day, up to a maximum of five days.

Throughout your stay in the Intensive Care Unit (ICU), and up to certain days after you leave the ICU (days 7, 14, 21, and 28), the study team will carry out regular checks. These include monitoring your health, taking blood samples, and asking how you feel. If you leave the ICU and go to a regular hospital ward before day 28, most of your study assessments will stop, except for a final check at day 28. There will also be one final check-in about how you are feeling 90 days after you leave the ICU. You can withdraw from the study at any time without affecting your medical care.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of this study is that the NucleoCapture device might help reduce harmful substances in your blood, which could potentially lead to a better recovery from your pancreatitis. However, as this is a new treatment, we don't know for sure if it will be beneficial or if there are any unexpected risks. There could be side effects from the treatment, or the processes involved in the treatment could cause discomfort or complications, such as issues related to blood access or reactions during blood filtration. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Liverpool University Hospitals NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom

Common questions

What is acute pancreatitis?

It's a sudden and severe inflammation of your pancreas, an organ in your tummy that helps with digestion.

What is the NucleoCapture device?

It's a special device designed to filter your blood outside your body, removing harmful substances that can make pancreatitis worse.

Will I definitely get the new treatment?

No, participants are randomly assigned to either receive standard care only or standard care plus the NucleoCapture treatment.

How long will the treatment sessions be?

Each treatment session with the NucleoCapture device will last up to six hours.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won’t affect your medical care.

How to find out more

Heather Rogers

heather.rogers@liverpoolft.nhs.uk +44 151 706 3702 Official trial record

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