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Safety and Efficacy of hiHep Bioartificial Liver Support System to Treat Acute Liver Failure

NCT03084198 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-04-25

No results posted yet for this study

Summary

This study tend to evaluate safety and efficacy of hiHep bioartificial liver support system in treating acute liver failure.

Conditions

  • Liver Failure, Acute

Interventions

PROCEDURE

hiHep Bioartificial Liver Support System

Continuous treatment with the hiHep bioartificial liver support system for a minimum of 3 days to a maximum of 14 days. The subject's ultrafiltrated blood is circulated through 4 cartridges. The parameter is set to Circuit 1：120-200ml/min；Circuit 2：30-50ml/min；Circuit 3：200 ml/min.

PROCEDURE

Standard care for ALF

A standard of care for subjects with acute liver failure.

Sponsors & Collaborators

  • Chinese Academy of Sciences

    collaborator OTHER_GOV

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Shaolin Ma, MD. · Department of ICU, Shanghai East Hospital, School of Medicine, Tongji University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2020-06-30
Completion
2020-06-30

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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 NCT03084198 on ClinicalTrials.gov