Early Liver Support With MARS in Post-hepatectomy Liver Failure

NCT03761238 | Unknown FDA Device

• 1 other identifier: ELISH
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, randomized, open-label, multicentre study involving European centers with experience in the management of PHLF to assess the impact of early liver support with MARS on survival in patients with post-hepatectomy liver failure (PHLF).

Conditions

Liver Failure as A Complication of Care

Keywords

Molecular Adsorbent Recirculating System; post-hepatectomy liver failure; liver dialysis; post-hepatectomy liver dysfunction

Outcome Measures

Primary Outcomes (1)

• 60 day survival

  Overall survival rate from time of randomization to death from any cause

  From randomization to death from any cause, assessed up to 60 days postop

Secondary Outcomes (21)

• 28 day survival

  From randomization to death from any cause, assessed up to 28 days post-op

• 90 day survival

  From randomization to death from any cause, assessed up to 90 days postop

• 6 month survival

  From randomization to death from any cause, assessed up to 6 months postop

• 1 year survival

  From randomization to death from any cause, assessed up to 1 year.

• Impact of MARS therapy on liver function

  From randomization up to 1 year.

Study Arms (2)

Standard medical treatment + MARS

EXPERIMENTAL

Patients assigned to the control arm will receive standard medical treatment (SMT) and liver dialysis using Molecular Adsorbent Recirculating System (MARS).

Device: Molecular Adsorbent Recirculating System

Standard medical treatment

ACTIVE COMPARATOR

Patients assigned to the control arm will receive standard medical treatment (SMT) as specified in the study protocol.

Other: Standard medical treatment (SMT)

Interventions

Molecular Adsorbent Recirculating System DEVICE

MARS therapy will start within 24-48 h after randomization and be given on 3 consecutive days in sessions of 8-12 h. The patients are observed for 2 days following the last session, with focus on bilirubin INR and signs of encephalopathy, and can thereafter receive 3 additional sessions in case of no or partial response to treatment.

Also known as: MARS 1116/1 - X-MARS

Standard medical treatment + MARS

Standard medical treatment (SMT) OTHER

Patient management and standard medical treatment (SMT) as specified in the study protocol.

Standard medical treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients subjected for major liver surgery (4 or more Couinaud segments) or patients undergoing a 2nd, 3rd or 4th hepatic resection. Pre-operative chemotherapy and/or biological agents are allowed.
• Primary PHLF occurring early after surgery defined by the 50:50 criteria (from PO day 5 to day 14) or by the presence of hepatic encephalopathy grade 2 or more and the 50:50 criteria (from PO day 3 to 4).
• Written informed consent.

You may not qualify if:

• ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) procedure.
• In patients with chronic liver disease presence of significant portal hypertension (hepatic venous pressure gradient ≥ 10 mmHg and/or Fibroscan ≥ 21kPa) prior to surgical intervention.
• Any contraindication for MARS therapy such as uncontrolled active bleeding, platelet counts \<20.000 /µl or uncontrolled infection (presence of fever or adequate antibiotic therapy for less than 48h), septic shock, haemodynamic instability requiring inotropic support (noradrenaline \> 1mg/h).
• PHLF occurring after post operative day 14.
• Secondary PHLF: post-operative liver failure secondary to vascular (outflow or inflow thrombosis) or septic problems.
• Persistant biliary complications (infected biloma, main biliary tree damage).
• Inability or unwilling of the patient or family to give informed consent.

Sponsors & Collaborators

• Stefan Gilg, MD, PhD: lead

Study Officials

• Stefan Gilg, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Gilg, MD PhD

CONTACT

0702677722; stefan.gilg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 3, 2018
• Study Start: March 15, 2019
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2022
• Last Updated: December 3, 2018

Record last verified: 2018-11