An interventional study of NucleoCapture device in Acute Pancreatitis and Organ Failure, Multiple, sponsored by Liverpool University Hospitals NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Liverpool University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Liverpool University Hospitals NHS Foundation Trust is the lead sponsor of 61 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of severe multiple organ failure at the point of enrolment as evidenced by:
Severe vasoplegic failure
Concomitant cardiogenic shock, clinically suspected or cardiac index \<2.2 L/min/m2 if measured
Calculated Plasma Volume greater than 5000ml as determined by the following formula:
Vplasma = Vblood x (1 - haematocrit)
Where:
Vplasma = PV Vblood = an estimation of total blood volume (TBV; according to Nadler's formula, incorporating height, weight and sex).
A TBV calculator is available at https://www.omnicalculator.com/health/blood-volume
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the treatment arm will receive SOC plus three apheresis treatment sessions with the NucleoCapture device. The device consists of 100ml NucleoCapture selective adsorber.
Device: NucleoCapture device
Participants in the SOC arm will receive SOC alone, in accordance with ESICM guidelines.
100ml NucleoCapture selective DNA adsorber.
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
Exploratory evaluation of the correlation between NucleoCapture treatment and levels of routine biomarkers.
Routine organ function, haematology, coagulation and inflammation biomarkers will be measured.
Time frame: At baseline, days 1 to 5, 7, 14 and 21.
Exploratory evaluation of the correlation between NucleoCapture treatment and levels of non-routine biomarkers.
Non-routine biomarkers of inflammation and coagulation will be measured.
Time frame: At baseline, days 1 to 5, day 7 and day 14.
Device handling and usability.
Usability and handling of the device will be assessed in the intervention arm using a questionnaire.
Time frame: Day 1 to day 5.
Patient reported outcome (PROMs) - PAN PROMISE acute pancreatitis symptom scale
Quantify the symptoms of acute pancreatitis via PROM.
Time frame: Baseline, at discharge from the ICU up to day 28, and at 90 days post discharge from the ICU.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Dec 2026, 12 months later.
Of 91 non-industry interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 12 months is below that.
Counting every sponsor, half of 94 studies reached it within 32 months; a quarter within 23 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Liverpool University Hospitals NHS Foundation Trust