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

Launched by LIVERPOOL UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment device called NucleoCapture, which is designed to help reduce harmful substances in the blood known as cell-free DNA (cfDNA) and Neutrophil Extracellular Traps (NETs) in patients with severe acute pancreatitis. Acute pancreatitis is a sudden inflammation of the pancreas that can lead to serious complications if not treated properly. The study will assess how safe and effective this device is when used on patients who are experiencing severe symptoms and organ failure, such as problems with their lungs, heart, or kidneys.

To participate in this trial, you must be an adult (18 years or older) with a confirmed case of acute pancreatitis and experiencing significant organ issues. However, there are several conditions that would prevent someone from joining, such as severe organ failure, certain blood disorders, or if you are already part of another clinical study. If you participate, you can expect to undergo treatment with the NucleoCapture device, with the hope of improving your condition. The trial is currently not recruiting patients, but it could provide important insights into better management of acute pancreatitis in the future.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients aged 18 or over
• • 2. 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)
• • 3. Any aetiology
• • 4. 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
• • 5. 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 Criteria:
• • 6. 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).
• 7. 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
• 8. 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
• • 9. Known liver cirrhosis (histologically proven or clinically suspected)
• • 10. Active bleeding
• • 11. Known citrate intolerance if citrate is required for therapeutic apheresis
• • 12. Known heparin allergy if heparin is required for therapeutic apheresis
• • 13. Known metastatic disease with life expectancy of \<12 months and ECOG score of at least 2
• • 14. Known haematological malignancy if not in remission
• • 15. Known solid organ transplant and concomitant use of immunosuppression
• • 16. Known long term oxygen therapy or Home oxygen use
• • 17. Dialysis dependent Chronic Kidney Disease (CKD Stage 5-D)
• • 18. Planned or impending dialysis
• • 19. Prior use of cardiopulmonary resuscitation (CPR) in current admission
• • 20. Requirement for extracorporeal membrane oxygenation (ECMO)
• • 21. Patient expected to die within 48 hours of admission to ICU
• • 22. Known allergy to components of NucleoCapture (Sepharose beads and linker histone H1.3)
• • 23. Pre-existing disease of the exocrine pancreas including chronic pancreatitis, recurrent acute pancreatitis, pancreatic malignancy and/or history of pancreatic surgery
• • 24. Chronic neuromuscular disease affected breathing
• • 25. Current Participation in another interventional clinical study
• • 26. Pregnancy (as established by the presence of beta human chorionic gonadotropin in urine or blood)