Use of HA 330-II for Hemofiltration in Patients With ALF as a Bridge to Liver Transplantation .

NCT04243655 | Unknown Phase 4

• 1 other identifier: AIG-G/ALFLD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

ALF (ALF) is defined by three criteria: (1) rapid development of hepatocellular dysfunction (jaundice, coagulopathy), (2) hepatic encephalopathy, and (3) absence of a prior history of liver disease. Interval between onset of acute hepatic injury (jaundice) and onset of liver failure (encephalopathy with or without coagulopathy) in such patients (icterus-encephalopathy interval; IEI) has been described to be between 4 weeks (Indian definition) to 24 weeks (AASLD-ALF study group). Further, due to the diverse natural course, ALF has been sub-classified as hyperacute (IEI ≤ 7 day), acute (IEI ≤ 4 weeks) and sub-acute ALF (IEI ≥ 5 week to ≤12 weeks) by British authors.

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Efficacy of HA 330-II to prolong liver-transplantation free survival.

  The length of survival time after first hemofiltration treatment during the follow-up period.

  Up to 30 Days

Secondary Outcomes (4)

• Change in Systemic inflammatory response syndrome (SIRS) score.

  Up to 7 Days, post hemofiltration

• Change in Acute Physiology and Chronic Health Evaluation (APACHE-II) score.

  Up to 7 Days, post hemofiltration

• Change in sequential organ failure assessment (SOFA) score.

  Up to 7 Days, post hemofiltration

• Change in chronic liver failure-sequential organ failure assessment (CLIF-SOFA) score.

  Up to 7 Days, post hemofiltration

Study Arms (2)

Hemoperfusion treatment with HA 330-II

EXPERIMENTAL

Hemoperfusion treatment with HA 330-II, one unit for 2-4 hours treatment, for 3 consecutive days along with SMT as per patients requirement.

Device: HA 330-II; Drug: Standard medical treatment (SMT)

Standard medical treatment (SMT)

ACTIVE COMPARATOR

SMT as per patients requirement- Management of cerebral edema/intracranial hypertension: prophylactic antibiotics, administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, volume replacement and pressor support (noradrenaline, doubutamine, dopamine) as needed, NAC and correction of metabolic parameters.

Drug: Standard medical treatment (SMT)

Interventions

HA 330-II DEVICE

One unit for 2-4 hours treatment, for 3 consecutive days

Hemoperfusion treatment with HA 330-II

Standard medical treatment (SMT) DRUG

SMT as per patients requirement- Management of cerebral edema/intracranial hypertension: prophylactic antibiotics, administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, volume replacement and pressor support (noradrenaline, doubutamine, dopamine) as needed, NAC and correction of metabolic parameters.

Hemoperfusion treatment with HA 330-II; Standard medical treatment (SMT)

Eligibility Criteria

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

You may qualify if:

• Acute Liver Failure patients with SIRS and Hepatic Encephalopathy, without hyperbilirubinemia.

You may not qualify if:

• Patients with age less than 18 years or more than 65 years
• Extremely moribund patients with an expected life expectancy of less than 24 hours or with poor prognosis
• With poor blood clotting function and PTA \<30%.
• Active Bleed
• Chronic heart, lung or kidney disease
• Malignant tumors including liver cancer
• Past history of organ transplantation

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute Of Gastroenterology

Hyderabad, Telangana, 500032, India

RECRUITING

Related Publications (3)

• Rolando N, Wade J, Davalos M, Wendon J, Philpott-Howard J, Williams R. The systemic inflammatory response syndrome in acute liver failure. Hepatology. 2000 Oct;32(4 Pt 1):734-9. doi: 10.1053/jhep.2000.17687.

  PMID: 11003617 BACKGROUND

• Lee KC, Stadlbauer V, Jalan R. Extracorporeal liver support devices for listed patients. Liver Transpl. 2016 Jun;22(6):839-48. doi: 10.1002/lt.24396.

  PMID: 26785141 BACKGROUND

• Larsen FS, Schmidt LE, Bernsmeier C, Rasmussen A, Isoniemi H, Patel VC, Triantafyllou E, Bernal W, Auzinger G, Shawcross D, Eefsen M, Bjerring PN, Clemmesen JO, Hockerstedt K, Frederiksen HJ, Hansen BA, Antoniades CG, Wendon J. High-volume plasma exchange in patients with acute liver failure: An open randomised controlled trial. J Hepatol. 2016 Jan;64(1):69-78. doi: 10.1016/j.jhep.2015.08.018. Epub 2015 Aug 29.

  PMID: 26325537 BACKGROUND

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Mithun Sharma

  AIG Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mithun Sharma, MD, DM

CONTACT

08790622655; drmithunsharma@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hemoperfusion treatment with HA 330-II, one unit for 2-4 hours treatment, for 3 consecutive days along with standard medical treatment (SMT) as per patients requirement.

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 28, 2020
• Study Start: December 30, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 31, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

IN (1)