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

Not Applicable

Not yet recruiting

• Conditions: Acute Pancreatitis; Organ Failure, Multiple

• Registration Number: NCT06566638
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Adult patients aged 18 or over<br><br> 2. Acute pancreatitis (following revised Atlanta definition of 2 out of typical pain,<br> serum amylase >3x normal range and/or CT/MRI imaging consistent with pancreatitis)<br><br> 3. Any aetiology<br><br> 4. Acute respiratory (PaO2/FiO2 <300), cardiovascular (systolic BP <90 or any inotropic<br> therapy) or renal failure (serum creatinine >170 µmol/l, or deterioration of >50%<br> eGFR if pre-existing renal disease or urine output <0.5ml/kg/hr for 3 consecutive<br> hours) presenting at any point during the index admission and persistent after 12 h<br> of fluid resuscitation, but for not more than 72 hours<br><br> 5. Have provided written informed consent or consent is given by the patient's legally<br> designated representative or an independent physician (if possible, according to<br> local law).<br><br> Exclusion Criteria:<br><br> 6. The use of other non-routine extracorporeal treatments such as very high flux renal<br> replacement therapy (>60ml/kg/h total exchange), use of high cut off filters or<br> other non-routine extracorporeal treatment columns such as Cytosorb, Toramyxcin,<br> etc).<br><br> 7. Presence of severe multiple organ failure at the point of enrolment as evidenced by:<br><br> - Severe refractory vasoplegic failure<br><br> - Norepinephrine dose > 0.60 µg/kg/min<br><br> - Use of epinephrine<br><br> - Concomitant cardiogenic shock, clinically suspected or cardiac index <2.2<br> L/min/m2 if measured<br><br> - Use of dobutamine, epinephrine, phosphodiesterase inhibitors or<br> levosimendan<br><br> - Coagulopathy as defined by Platelet count <50x10^9/L<br><br> 8. Calculated Plasma Volume greater than 5000ml as determined by the following formula:<br><br> Vplasma = Vblood x (1 - haematocrit)<br><br> Where:<br><br> Vplasma = PV Vblood = an estimation of total blood volume (TBV; according to<br> Nadler's formula, incorporating height, weight and sex).<br><br> A TBV calculator is available at https://www.omnicalculator.com/health/blood-volume<br><br> 9. Known liver cirrhosis (histologically proven or clinically suspected)<br><br> 10. Active bleeding<br><br> 11. Known citrate intolerance if citrate is required for therapeutic apheresis<br><br> 12. Known heparin allergy if heparin is required for therapeutic apheresis<br><br> 13. Known metastatic disease with life expectancy of <12 months and ECOG score of at<br> least 2<br><br> 14. Known haematological malignancy if not in remission<br><br> 15. Known solid organ transplant and concomitant use of immunosuppression<br><br> 16. Known long term oxygen therapy or Home oxygen use<br><br> 17. Dialysis dependent Chronic Kidney Disease (CKD Stage 5-D)<br><br> 18. Planned or impending dialysis<br><br> 19. Prior use of cardiopulmonary resuscitation (CPR) in current admission<br><br> 20. Requirement for extracorporeal membrane oxygenation (ECMO)<br><br> 21. Patient expected to die within 48 hours of admission to ICU<br><br> 22. Known allergy to components of NucleoCapture (Sepharose beads and linker histone<br> H1.3)<br><br> 23. Pre-existing disease of the exocrine pancreas including chronic pancreatitis,<br> recurrent acute pancreatitis, pancreatic malignancy and/or history of pancreatic<br> surgery<br><br> 24. Chronic neuromuscular disease affected breathing<br><br> 25. Current Participation in another interventional clinical study<br><br> 26. Pregnancy (as established by the presence of beta human chorionic gonadotropin in<br> urine or blood)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of cfDNA/NETs in the plasma of patients with severe acute pancreatitis after each NucleoCapture treatment.

Secondary Outcome Measures

Name	Time	Method
The amount of cfDNA/NETs in the circulating blood in patients after treatment with NucleoCapture compared to standard of care.;Change in organ in support;28-day survival;ICU length of stay;Hospital length of stay