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

NCT06307158 | Completed

• 1 other identifier: CT2024-ZJU-OBS1
• Study Type: observational
• Target: 998
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Postoperative recurrence of liver cancer

  The overall incidence of HCC recurrence (intrahepatic or extrahepatic) after LT.

  2015.1.1-2020.12.31

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead
• Shulan (Hangzhou) Hospital: collaborator

Related Publications (1)

• Yang M, Wei X, Shu W, Zhai X, Zhou Z, Cai J, Yang J, Jin B, Zheng S, Xu X. Influence of intraoperative blood salvage and autotransfusion on tumor recurrence after deceased donor liver transplantation: a large nationwide cohort study. Int J Surg. 2024 Sep 1;110(9):5652-5661. doi: 10.1097/JS9.0000000000001683.

  PMID: 38847771 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: January 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share