Status:
NOT_YET_RECRUITING
Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA/NETs in Subjects With Pancreatitis
Lead Sponsor:
Liverpool University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Santersus AG
Conditions:
Acute Pancreatitis
Organ Failure, Multiple
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
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 gast...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06566638
Start Date
December 1 2025
End Date
April 1 2027
Last Update
March 20 2025
Active Locations (1)
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1
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom