[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559631":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":18,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Liverpool University Hospitals NHS Foundation Trust","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: NucleoCapture device",{"label":15,"type":16,"description":17,"interventionNames":18},"SOC","NO_INTERVENTION","Participants in the SOC arm will receive SOC alone, in accordance with ESICM guidelines.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","NucleoCapture device","100ml NucleoCapture selective DNA adsorber.",[9],[26],{"name":27,"affiliation":5,"role":28},"Peter Szatmary","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Heather Rogers","CONTACT","+44 151 706 3702","Heather.Rogers@liverpoolft.nhs.uk",[36],{"facility":5,"status":18,"city":37,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Liverpool","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-2.97794,53.41058,{"lat":44,"lon":43},[47],{"name":27,"role":32,"phone":18,"phoneExt":18,"email":48},"Peter.Szatmary@liverpoolft.nhs.uk",{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[52],{"name":53,"class":54},"Santersus AG","INDUSTRY","100559631","safety-tolerability-and-performance-of-the-nucleocapture-extracorporeal-therapeutic-apheresis-device-in-the-reduction-of-circulating-cfdnanets-in-subjects-with-pancreatitis-100559631",false,"NCT06566638","Safety, Tolerability and Performance of the NucleoCapture Extracorporeal Therapeutic Apheresis Device in the Reduction of Circulating cfDNA\u002FNETs in Subjects With Pancreatitis","NUC-SAP1","Inclusion Criteria:\n\n1. Adult patients aged 18 or over\n2. Acute pancreatitis (following revised Atlanta definition of 2 out of typical pain, serum amylase \\>3x normal range and\u002For CT\u002FMRI imaging consistent with pancreatitis)\n3. Any aetiology\n4. Acute respiratory (PaO2\u002FFiO2 \\\u003C300), cardiovascular (systolic BP \\\u003C90 or any inotropic therapy) or renal failure (serum creatinine \\>170 µmol\u002Fl, or deterioration of \\>50% eGFR if pre-existing renal disease or urine output \\\u003C0.5ml\u002Fkg\u002Fhr 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\n5. 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).\n\n   Exclusion Criteria:\n6. The use of other non-routine extracorporeal treatments such as very high flux renal replacement therapy (\\>60ml\u002Fkg\u002Fh total exchange), use of high cut off filters or other non-routine extracorporeal treatment columns such as Cytosorb, Toramyxcin, etc).\n7. Presence of severe multiple organ failure at the point of enrolment as evidenced by:\n\n   * Severe refractory vasoplegic failure\n\n     * Norepinephrine dose \\> 0.60 μg\u002Fkg\u002Fmin\n     * Use of epinephrine\n   * Concomitant cardiogenic shock, clinically suspected or cardiac index \\\u003C2.2 L\u002Fmin\u002Fm2 if measured\n\n     * Use of dobutamine, epinephrine, phosphodiesterase inhibitors or levosimendan\n   * Coagulopathy as defined by Platelet count \\\u003C50x10\\^9\u002FL\n8. Calculated Plasma Volume greater than 5000ml as determined by the following formula:\n\n   Vplasma = Vblood x (1 - haematocrit)\n\n   Where:\n\n   Vplasma = PV Vblood = an estimation of total blood volume (TBV; according to Nadler's formula, incorporating height, weight and sex).\n\n   A TBV calculator is available at https:\u002F\u002Fwww.omnicalculator.com\u002Fhealth\u002Fblood-volume\n9. Known liver cirrhosis (histologically proven or clinically suspected)\n10. Active bleeding\n11. Known citrate intolerance if citrate is required for therapeutic apheresis\n12. Known heparin allergy if heparin is required for therapeutic apheresis\n13. Known metastatic disease with life expectancy of \\\u003C12 months and ECOG score of at least 2\n14. Known haematological malignancy if not in remission\n15. Known solid organ transplant and concomitant use of immunosuppression\n16. Known long term oxygen therapy or Home oxygen use\n17. Dialysis dependent Chronic Kidney Disease (CKD Stage 5-D)\n18. Planned or impending dialysis\n19. Prior use of cardiopulmonary resuscitation (CPR) in current admission\n20. Requirement for extracorporeal membrane oxygenation (ECMO)\n21. Patient expected to die within 48 hours of admission to ICU\n22. Known allergy to components of NucleoCapture (Sepharose beads and linker histone H1.3)\n23. Pre-existing disease of the exocrine pancreas including chronic pancreatitis, recurrent acute pancreatitis, pancreatic malignancy and\u002For history of pancreatic surgery\n24. Chronic neuromuscular disease affected breathing\n25. Current Participation in another interventional clinical study\n26. Pregnancy (as established by the presence of beta human chorionic gonadotropin in urine or blood)","ALL","18 Years",{"count":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"NA","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)\u002FNeutrophil Extracellular Traps (NETs) in patients with severe acute pancreatitis.",[72,73],"Acute Pancreatitis","Organ Failure, Multiple",[75,76,77,78,79],"Acute pancreatitis","NucleoCapture","Extracorporeal","Apheresis","Neutrophil extracellular traps","NOT_YET_RECRUITING","2025-03-17",{"date":83,"type":84},"2025-03-20","ACTUAL",{"date":86,"type":66},"2025-12-01",{"date":88,"type":66},"2027-04-01",{"name":5,"class":6},1]