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Clinical Trial Summary

It is a prospective, non-randomized, single-arm cohort study. A total of 10 patients will be included in this study. Based on standardized treatment, the treatment of bioartificial liver device will be applied 24-48 hours after extensive hepatectomy. In order to evaluate the security and effectiveness of the device, liver function, liver volume, the incidence of liver failure and other results will be analyzed.

Clinical Trial Description

Include large-scale hepatectomy patients who meet the Inclusion criteria into the experimental group. Patient will be sent to ICU monitoring after surgery , the investigators will evaluate the blood routine, liver and kidney function, blood coagulation function, and immune inflammation indicators on the first day after surgery, and large veins will be temporarily indwelled within 24-48 hours Hemodialysis tube, then take artificial liver treatment which lasts 6-9h, follow-up test results on the 1st day, 3rd day, 7th day, 1 month and 3 months about blood routine, liver and kidney function, coagulation function, blood ammonia, Immune inflammation indicators, imaging examinations (CT or MR) at 7 days, 1 month and 3 months after treatment, to evaluate the recovery of liver function and liver regeneration after artificial liver treatment. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05035108
Study type Interventional
Source Sir Run Run Shaw Hospital
Contact Xiujun Cai, MD
Phone 0086-0571-86006605
Email [email protected]
Status Recruiting
Phase Early Phase 1
Start date November 10, 2020
Completion date December 30, 2021