Acute PancreatitisNUC-SAP1NCT06566638
Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA/NETs in Subjects With Pancreatitis
A study testing NucleoCapture device in people with Acute Pancreatitis and Organ Failure, Multiple, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Organ Failure, Multiple
- What is being tested?
- NucleoCapture device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2025to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 or over
- Acute pancreatitis (following revised Atlanta definition of 2 out of typical pain, serum amylase >3x normal range and/or CT/MRI imaging consistent with pancreatitis)
- Any aetiology
- Acute respiratory (PaO2/FiO2 <300), cardiovascular (systolic BP <90 or any inotropic therapy) or renal failure (serum creatinine >170 µmol/l, or deterioration of >50% eGFR if pre-existing renal disease or urine output <0.5ml/kg/hr for 3 consecutive hours) presenting at any point during the index admission and persistent after 12 h of fluid resuscitation, but for not more than 72 hours
- Have provided written informed consent or consent is given by the patient's legally designated representative or an independent physician (if possible, according to local law).
Who cannot join
- The use of other non-routine extracorporeal treatments such as very high flux renal replacement therapy (>60ml/kg/h total exchange), use of high cut off filters or other non-routine extracorporeal treatment columns such as Cytosorb, Toramyxcin, etc).
- Presence of severe multiple organ failure at the point of enrolment as evidenced by:
- Severe refractory vasoplegic failure
- Norepinephrine dose > 0.60 μg/kg/min
- Use of epinephrine
- Concomitant cardiogenic shock, clinically suspected or cardiac index <2.2 L/min/m2 if measured
Show all 31Show fewer
- Use of dobutamine, epinephrine, phosphodiesterase inhibitors or levosimendan
- Coagulopathy as defined by Platelet count <50x10^9/L
- 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
- Known liver cirrhosis (histologically proven or clinically suspected)
- Active bleeding
- Known citrate intolerance if citrate is required for therapeutic apheresis
- Known heparin allergy if heparin is required for therapeutic apheresis
- Known metastatic disease with life expectancy of <12 months and ECOG score of at least 2
- Known haematological malignancy if not in remission
- Known solid organ transplant and concomitant use of immunosuppression
- Known long term oxygen therapy or Home oxygen use
- Dialysis dependent Chronic Kidney Disease (CKD Stage 5-D)
- Planned or impending dialysis
- Prior use of cardiopulmonary resuscitation (CPR) in current admission
- Requirement for extracorporeal membrane oxygenation (ECMO)
- Patient expected to die within 48 hours of admission to ICU
- Known allergy to components of NucleoCapture (Sepharose beads and linker histone H1.3)
- Pre-existing disease of the exocrine pancreas including chronic pancreatitis, recurrent acute pancreatitis, pancreatic malignancy and/or history of pancreatic surgery
- Chronic neuromuscular disease affected breathing
- Current Participation in another interventional clinical study
- Pregnancy (as established by the presence of beta human chorionic gonadotropin in urine or blood)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Liverpool University Hospitals NHS Foundation Trust
Liverpool
Peter Szatmary, Peter.Szatmary@liverpoolft.nhs.uk
About this study
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.
Read the 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
- Being tested
- NucleoCapture device
- Keywords
- Acute pancreatitis, NucleoCapture, Extracorporeal, Apheresis, Neutrophil extracellular traps
- Medical subject headings
- Pancreatitis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NucleoCapture deviceDevice
100ml NucleoCapture selective DNA adsorber.
| Study group | Role | What they receive |
|---|---|---|
| SOC plus NucleoCapture | Experimental | 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. Receives: Device: NucleoCapture device |
| SOC | No intervention | Participants in the SOC arm will receive SOC alone, in accordance with ESICM guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 hours from the baseline once 4.5 plasma volumes has been treated.
Secondary outcomes (5)
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.
Measured: 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
Measured: From date of randomisation to Day 5
28-day survival
Survival up to 28 days
Measured: 28 days
ICU length of stay
The length of stay in the ICU
Measured: Up to 28 days.
Hospital length of stay
The length of stay in up to hospital discharge
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Dec 2025 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the control arm (SOC) or the treatment arm (SOC plus NucleoCapture) in a 1:1.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Santersus AG
- Responsible party
- Sponsor
- Investigators
- Peter Szatmary, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566638
- Sponsor's protocol ID
- LHS0096
- Acronym
- NUC-SAP1
- Status last verified
- Jul 2024
- First submitted
- 7 Aug 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA/NETs in Subjects With Pancreatitis
- ClinicalTrials.gov ID
- NCT06566638
- Acronym / sponsor ID
- NUC-SAP1 / LHS0096
- Conditions
- Acute Pancreatitis, Organ Failure, Multiple
- Keywords
- Acute pancreatitis, NucleoCapture, Extracorporeal, Apheresis, Neutrophil extracellular traps
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- Santersus AG
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the control arm (SOC) or the treatment arm (SOC plus NucleoCapture) in a 1:1.
| Arm | Type | Receives |
|---|---|---|
| SOC plus NucleoCapture | Experimental | Device: NucleoCapture deviceParticipants in the treatment arm will receive SOC plus three apheresis treatment sessions with the NucleoCapture device. The device consists of 100ml NucleoCapture selective adsorber. |
| SOC | No intervention | –Participants in the SOC arm will receive SOC alone, in accordance with ESICM guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18 or over
- Acute pancreatitis (following revised Atlanta definition of 2 out of typical pain, serum amylase >3x normal range and/or CT/MRI imaging consistent with pancreatitis)
- Any aetiology
- Acute respiratory (PaO2/FiO2 <300), cardiovascular (systolic BP <90 or any inotropic therapy) or renal failure (serum creatinine >170 µmol/l, or deterioration of >50% eGFR if pre-existing renal disease or urine output <0.5ml/kg/hr for 3 consecutive hours) presenting at any point during the index admission and persistent after 12 h of fluid resuscitation, but for not more than 72 hours
- Have provided written informed consent or consent is given by the patient's legally designated representative or an independent physician (if possible, according to local law).
Key exclusion criteria (31 listed)
- The use of other non-routine extracorporeal treatments such as very high flux renal replacement therapy (>60ml/kg/h total exchange), use of high cut off filters or other non-routine extracorporeal treatment columns such as Cytosorb, Toramyxcin, etc).
- Presence of severe multiple organ failure at the point of enrolment as evidenced by:
- Calculated Plasma Volume greater than 5000ml as determined by the following formula:
- Vplasma = Vblood x (1 - haematocrit)
- Vplasma = PV Vblood = an estimation of total blood volume (TBV; according to Nadler's formula, incorporating height, weight and sex).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NucleoCapture device100ml NucleoCapture selective DNA adsorber. | Device | SOC plus NucleoCapture |
Primary outcome
The amount of cfDNA/NETs in the plasma of patients with severe acute pancreatitis after each NucleoCapture treatment.
Time frame: Within 6 hours from the baseline once 4.5 plasma volumes has been treated.
The change in the levels of cfDNA/NETs across the NucleoCapture column at the end of each NucleoCapture treatment session.
5 secondary outcomes
The amount of cfDNA/NETs in the circulating blood in patients after treatment with NucleoCapture compared to standard of care.
Time frame: Within 6 hours from the baseline once 4.5 plasma volumes has been treated.
Change in organ in support
Time frame: From date of randomisation to Day 5
28-day survival
Time frame: 28 days
ICU length of stay
Time frame: Up to 28 days.
Hospital length of stay
Time frame: Up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Szatmary principal investigator
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NucleoCapture device in people with Acute Pancreatitis and Organ Failure, Multiple, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Rogers (+44 151 706 3702, Heather.Rogers@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of cfDNA/NETs in the plasma of patients with severe acute pancreatitis after each NucleoCapture treatment. (time frame: Within 6 hours from the baseline once 4.5 plasma volumes has been treated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.