Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation

The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis.

Study Overview

• Status: Completed
• Conditions: Liver Transplant; Complications

• Study Type: Observational
• Enrollment (Actual): 998

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A retrospective review was conducted on the prospectively maintained liver transplantation database of the CLTR. The initial data collection included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020.

Description

Inclusion Criteria:

• adult-to-adult deceased donor liver transplantation for hepatocellular carcinoma

Exclusion Criteria:

• patients under 18 years of age
• presence of extrahepatic metastasis
• combined kidney transplantation
• reduced-size or split liver transplantation
• re-transplantation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Intraoperative blood salvage and autotransfusion (IBSA) group; The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria included: patients under 18 years of age, presence of extrahepatic metastasis, combined kidney transplantation, reduced-size or split liver transplantation, re-transplantation, and missing data on analyzed variables. The remaining recipients were 349 in IBSA group who received salvaged blood autotransfusion during the LT.
non-intraoperative blood salvage and autotransfusion (non-IBSA) group; The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria was as mentioned ahead. Recipients who did not receive salvaged blood autotransfusion during the LT were enrolled in non-IBSA group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative recurrence of liver cancer	The overall incidence of HCC recurrence (intrahepatic or extrahepatic) after LT.	2015.1.1-2020.12.31

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Shulan (Hangzhou) Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: CT2024-ZJU-OBS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No