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

NCT06566638 | Not Yet Recruiting DMC

• 1 other identifier: LHS0096
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Pancreatitis; Organ Failure, Multiple

Keywords

Acute pancreatitis; NucleoCapture; Extracorporeal; Apheresis; Neutrophil extracellular traps

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Within 6 hours from the baseline once 4.5 plasma volumes has been treated.

• Change in organ in support

  From date of randomisation to Day 5

• 28-day survival

  28 days

• ICU length of stay

  Up to 28 days.

• Hospital length of stay

  Up to 28 days

Other Outcomes (4)

• Exploratory evaluation of the correlation between NucleoCapture treatment and levels of routine biomarkers.

  At baseline, days 1 to 5, 7, 14 and 21.

• Exploratory evaluation of the correlation between NucleoCapture treatment and levels of non-routine biomarkers.

  At baseline, days 1 to 5, day 7 and day 14.

• Device handling and usability.

  Day 1 to day 5.

Study Arms (2)

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.

Device: NucleoCapture device

SOC

NO INTERVENTION

Participants in the SOC arm will receive SOC alone, in accordance with ESICM guidelines.

Interventions

NucleoCapture device DEVICE

100ml NucleoCapture selective DNA adsorber.

SOC plus NucleoCapture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• Santersus AG: collaborator

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Location

MeSH Terms

Conditions

Pancreatitis; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Szatmary

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Rogers

CONTACT

+44 151 706 3702; Heather.Rogers@liverpoolft.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either the control arm (SOC) or the treatment arm (SOC plus NucleoCapture) in a 1:1.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 22, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)