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Early Liver Support With MARS in Post-hepatectomy Liver Failure

NCT03761238 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-12-03

No results posted yet for this study

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

Interventions

DEVICE

Molecular Adsorbent Recirculating System

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.

OTHER

Standard medical treatment (SMT)

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

Sponsors & Collaborators

  • Stefan Gilg, MD, PhD

    lead OTHER

Principal Investigators

  • Stefan Gilg, MD PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2021-09-15
Completion
2022-09-15
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761238 on ClinicalTrials.gov