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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
100ml NucleoCapture selective DNA adsorber.
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
The amount of cfDNA/NETs in the plasma of patients with severe acute pancreatitis after each NucleoCapture treatment.
The change in the levels of cfDNA/NETs across the NucleoCapture column at the end of each NucleoCapture treatment session.
Time frame: Within 6 hours from the baseline once 4.5 plasma volumes has been treated.
The amount of cfDNA/NETs in the circulating blood in patients after treatment with NucleoCapture compared to standard of care.
The change in the levels of circulating cfDNA/NETS at the end of each NucleoCapture treatment session.
Time frame: Within 6 hours from the baseline once 4.5 plasma volumes has been treated.
Change in organ in support
Change in organ support will be assessed by the combined change in Inotrope e.g. norepinephrine dose, lactate, urine output, Horowitz index and oxygenation index compared to standard of care
Time frame: From date of randomisation to Day 5
28-day survival
Survival up to 28 days
Time frame: 28 days
ICU length of stay
The length of stay in the ICU
Time frame: Up to 28 days.
Hospital length of stay
The length of stay in up to hospital discharge
Time frame: Up to 28 days
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