HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification

NCT03312036 | Completed DMC

• 1 other identifier: 87/2012/O/Disp
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. The aim of this study is to assess efficacy and safety of CPFA in extracorporeal detoxification of liver toxins in patients affected by acute or acute-on-chronic liver failure.

Conditions

Liver Failure, Acute; Liver Failure, Acute on Chronic

Keywords

CPFA; Liver failure; Resin; detoxification

Outcome Measures

Primary Outcomes (1)

• The mortality reduction of patients with acute or acute on chronic liver failure;

  The measure is the overall survival of the patients after CPFA and standard medical therapy

  1 year

Secondary Outcomes (5)

• Efficacy of liver toxins detoxification

  1 year.

• Improvement of hepatic encephalopathy

  1 year

• Improvement of the arterial blood pressure of the patients

  1 year

• Biocompatibility of CPFA

  1 year

• Cytokines clearance during CPFA

  1 year

Study Arms (1)

CPFA Patients

EXPERIMENTAL

Patients affected by acute or acute on chronic liver failure who undergo Coupled plasma filtration and adsorption (CPFA) to recover their basal liver function or as a bridge to liver transplantation. The intervention is CPFA treatment which lasts 6 hour length. The intervention can be repeated for a maximum of 5 times.

Device: Coupled plasma filtration and adsorption (CPFA)

Interventions

Coupled plasma filtration and adsorption (CPFA) DEVICE

Patients affected by acute or acute on chronic liver failure are enrolled to undergo CPFA extracorporeal treatments and the standard medical therapy to recover their basal liver function or as a "bridge" to liver transplantation

CPFA Patients

Eligibility Criteria

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

You may qualify if:

• Acute liver failure
• Acute on chronic liver failure
• Bridge to liver transplantation

You may not qualify if:

• acute hemorrhage
• shock
• respiratory failure
• acute coronary syndrome
• psychiatric illnesses

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital

Bologna, Italy

Location

Related Publications (15)

• Ronco C, Brendolan A, d'Intini V, Ricci Z, Wratten ML, Bellomo R. Coupled plasma filtration adsorption: rationale, technical development and early clinical experience. Blood Purif. 2003;21(6):409-16. doi: 10.1159/000073444.

  PMID: 14586184 BACKGROUND

• Tetta C, Cavaillon JM, Schulze M, Ronco C, Ghezzi PM, Camussi G, Serra AM, Curti F, Lonnemann G. Removal of cytokines and activated complement components in an experimental model of continuous plasma filtration coupled with sorbent adsorption. Nephrol Dial Transplant. 1998 Jun;13(6):1458-64. doi: 10.1093/ndt/13.6.1458.

  PMID: 9641176 BACKGROUND

• Cole L, Bellomo R, Davenport P, Tipping P, Uchino S, Tetta C, Ronco C. The effect of coupled haemofiltration and adsorption on inflammatory cytokines in an ex vivo model. Nephrol Dial Transplant. 2002 Nov;17(11):1950-6. doi: 10.1093/ndt/17.11.1950.

  PMID: 12401852 BACKGROUND

• Ronco C, Brendolan A, Lonnemann G, Bellomo R, Piccinni P, Digito A, Dan M, Irone M, La Greca G, Inguaggiato P, Maggiore U, De Nitti C, Wratten ML, Ricci Z, Tetta C. A pilot study of coupled plasma filtration with adsorption in septic shock. Crit Care Med. 2002 Jun;30(6):1250-5. doi: 10.1097/00003246-200206000-00015.

  PMID: 12072677 BACKGROUND

• Formica M, Olivieri C, Livigni S, Cesano G, Vallero A, Maio M, Tetta C. Hemodynamic response to coupled plasmafiltration-adsorption in human septic shock. Intensive Care Med. 2003 May;29(5):703-8. doi: 10.1007/s00134-003-1724-0. Epub 2003 Mar 29.

  PMID: 12665998 BACKGROUND

• Mariano F, Tetta C, Stella M, Biolino P, Miletto A, Triolo G. Regional citrate anticoagulation in critically ill patients treated with plasma filtration and adsorption. Blood Purif. 2004;22(3):313-9. doi: 10.1159/000078788.

  PMID: 15256798 BACKGROUND

• Lentini P, Cruz D, Nalesso F, de Cal M, Bobek I, Garzotto F, Zanella M, Brendolan A, Piccinni P, Ronco C. [A pilot study comparing pulse high volume hemofiltration (pHVHF) and coupled plasma filtration adsorption (CPFA) in septic shock patients]. G Ital Nefrol. 2009 Nov-Dec;26(6):695-703. Italian.

  PMID: 19918752 BACKGROUND

• Mao HJ, Yu S, Yu XB, Zhang B, Zhang L, Xu XR, Wang XY, Xing CY. Effects of coupled plasma filtration adsorption on immune function of patients with multiple organ dysfunction syndrome. Int J Artif Organs. 2009 Jan;32(1):31-8. doi: 10.1177/039139880903200104.

  PMID: 19241361 BACKGROUND

• Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.

  PMID: 24401721 BACKGROUND

• Hughes RD. Review of methods to remove protein-bound substances in liver failure. Int J Artif Organs. 2002 Oct;25(10):911-7. doi: 10.1177/039139880202501003.

  PMID: 12456030 BACKGROUND

• Weiss JS, Gautam A, Lauff JJ, Sundberg MW, Jatlow P, Boyer JL, Seligson D. The clinical importance of a protein-bound fraction of serum bilirubin in patients with hyperbilirubinemia. N Engl J Med. 1983 Jul 21;309(3):147-50. doi: 10.1056/NEJM198307213090305.

  PMID: 6866015 BACKGROUND

• Gong D, Cruz D, Ronco C. Depurative capacity of molecular adsorbent recycling system (MARS): A focus on bilirubin removal. Int J Artif Organs. 2008 Oct;31(10):875-81. doi: 10.1177/039139880803101003.

  PMID: 19009505 BACKGROUND

• Harm S, Falkenhagen D, Hartmann J. Pore size--a key property for selective toxin removal in blood purification. Int J Artif Organs. 2014 Sep;37(9):668-78. doi: 10.5301/ijao.5000354. Epub 2014 Sep 23.

  PMID: 25262632 BACKGROUND

• Caroleo S, Rubino AS, Tropea F, Bruno O, Vuoto D, Amantea B, Renzulli A. Coupled plasma filtration adsorption reduces serum bilirubine in a case of acute hypoxic hepatitis secondary to cardiogenic shock. Int J Artif Organs. 2010 Oct;33(10):749-52.

  PMID: 21058270 BACKGROUND

• Maggi U, Nita G, Gatti S, Antonelli B, Paolo R, Como G, Messa P, Rossi G. Hyperbilirubinemia after liver transplantation: the role of coupled plasma filtration adsorption. Transplant Proc. 2013 Sep;45(7):2715-7. doi: 10.1016/j.transproceed.2013.07.019.

  PMID: 24034030 BACKGROUND

MeSH Terms

Conditions

Liver Failure, Acute; Acute-On-Chronic Liver Failure; Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Gaetano La Manna, Prof.

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. PhD

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 17, 2017
• Study Start: June 6, 2013
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)