NCT06566638

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Liverpool University Hospitals NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-centre, randomised-controlled, open-label, feasibility study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of circulating cell-free DNA (cfDNA)/Neutrophil Extracellular Traps (NETs) in patients with severe acute pancreatitis.

Detailed description

This study investigates the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in patients with acute pancreatitis. Acute pancreatitis is one of the leading gastrointestinal disorders that require urgent clinical care and is increasing in incidence. cfDNA/NET therapeutic apheresis with NucleoCapture is indicated for the treatment of diseases in which excessive levels of cfDNA/NETs are found, such as acute pancreatitis. Participants will be randomised to receive either standard of care (SOC) alone or SOC plus NucleoCapture treatment. SOC will be according to the current guidelines described by the European Society of Intensive Medicine (ESICM). Participants in the SOC plus NucleoCapture arm will receive one treatment session with NucleoCapture per day, for the first three days. Each treatment session with NucleoCapture will last for up 6 hours, aiming to treat 4.5 plasma volumes. Treatment sessions with NucleoCapture treating less than 3.5 plasma volumes will be counted as incomplete and the treatment session will be repeated on the following day, up to day 5 maximum. Assessments will take place for all participants whilst in the Intensive Care Unit (ICU) on days 1 to 5, 7, 14, 21 and 28, and at 90 days post discharge to ward-based care. Participants transferred to ward-based care before day 28 will receive no further study assessment visits from the point of transfer to ward-based care, apart from day 28 in which participants will receive a final study assessment visit and a patient reported outcome assessment (PROM) 90 days post discharge to ward-based care.

Conditions

• Acute Pancreatitis
• Organ Failure, Multiple

Interventions

Type	Name	Description
DEVICE	NucleoCapture device	100ml NucleoCapture selective DNA adsorber.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-05
• Completion: 2027-04-01
• First posted: 2024-08-22
• Last updated: 2025-03-20

Locations

1 site across 1 country: United Kingdom