NCT03761238

Early Liver Support With MARS in Post-hepatectomy Liver Failure

Early Liver Support With MARS in Post-hepatectomy Liver Failure: a Randomized, Multicentre Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Stefan Gilg, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

PHLF is a major risk factor for mortality in patients who underwent major hepatectomy. A specific treatment is yet not available. In a primary proof-of-concept study, it was shown that it is safe and feasible to use MARS in patients with PHLF early after hepatectomy. Survival was superior to a historical control group. This study will include patients with early, primary PHLF (based on the 50:50 criteria) after major liver surgery. Patients will be randomized 1:1 to receive standard treatment alone or standard treatment + liver dialysis using the Molecular Adsorbent Recirculating System (MARS). Relevant outcome along with several physiological parameters will be assessed.

Conditions

• Liver Failure as A Complication of Care

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-15
• Primary completion: 2021-09-15
• Completion: 2022-09-15
• First posted: 2018-12-03
• Last updated: 2018-12-03

Regulatory

• FDA-regulated device study