Skip to main content
OpenTrials
Completed

NCT Number: NCT02654028

Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection

This prospective non-randomized controlled trial aims to determine whether autotransfusion of red blood cells salvaged before liver resection is associated with the recurrence-free survival in patients with hepatocellular carcinoma.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 5350032, China

About this study

Preoperative and intraoperative blood salvage autotransfusion is used in various surgical procedures. However, because of the risk of reinfusion of salvaged blood contaminated by tumor cells, the use of autotransfusion in hepatocellular carcinoma (HCC) patients undergoing liver resection is controversial. The critical points include whether tumor cells can be cleared by autotransfusion, whether autotransfusion increases the risk of recurrence or metastasis, and what are the indications for autotransfusion. Moreover, some other issues are still not addressed. For example, is it warranted to take the risk of tumor dissemination by using autotransfusion to avoid allogeneic blood transfusion? Do the remaining tumor cells after additional filtration by leukocyte depletion filters still possess potential tumorigenicity?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent liver resection;
  • Diagnosis of hepatocellular carcinoma confirmed by postoperative histopathology;
  • Level of preoperative hemoglobin ≥110 g/L;
  • Child-Pugh class A or B liver function;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

Exclusion criteria

  • A history of other malignancies;
  • History of active autoimmune or immunodeficiency diseases;
  • Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;
  • Loss to follow-up.

Treatment and study plan

Autotransfusion

Procedure

These group of patients will receive autotransfusion before liver resection.

Control Group

Other

These group of patients will not receive autotransfusion before liver resection.

Primary outcomes

  1. Number of participants with tumor recurrence

    Time frame: 1-year

    The 1-year tumor recurrence will be compared between the two groups

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Registry information

Official study title

Association Between Autologous Transfusion and Recurrence-free Survival in Patients With Hepatocellular Carcinoma After Resection-a Prospective Non-randomized Controlled Trial

Acronym: AT/HCC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2016
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.