NCT02654028

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
618

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
3 years until next milestone

Study Start

First participant enrolled

January 5, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 10, 2016

Last Update Submit

January 21, 2023

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with tumor recurrence

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

    1-year

Study Arms (2)

Autotransfusion group

EXPERIMENTAL

These group of patients will receive autotransfusion before liver resection.

Procedure: Autotransfusion

Control group

ACTIVE COMPARATOR

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

Other: Control group

Interventions

AutotransfusionPROCEDURE

These group of patients will receive autotransfusion before liver resection.

Autotransfusion group
Control groupOTHER

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

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, 5350032, China

Location

Related Publications (3)

  • Han S, Kim G, Ko JS, Sinn DH, Yang JD, Joh JW, Lee SK, Gwak MS. Safety of the Use of Blood Salvage and Autotransfusion During Liver Transplantation for Hepatocellular Carcinoma. Ann Surg. 2016 Aug;264(2):339-43. doi: 10.1097/SLA.0000000000001486.

    PMID: 26501715BACKGROUND

  • Tomimaru Y, Eguchi H, Wada H, Hama N, Kawamoto K, Kobayashi S, Umeshita K, Doki Y, Mori M, Nagano H. Predicting the necessity of autologous blood collection and storage before surgery for hepatocellular carcinoma. J Surg Oncol. 2013 Dec;108(7):486-91. doi: 10.1002/jso.23426. Epub 2013 Sep 5.

    PMID: 24009154BACKGROUND

  • Kwon JH, Han S, Kim D, Kuk JH, Cho H, Kim S, Yang JD, Kim C, Kim JM, Choi GS, Joh JW, Ko JS, Gwak MS, Kim G. Blood Salvage and Autotransfusion With Single Leukoreduction Does Not Increase the Risk of Tumor Recurrence After Liver Transplantation for Advanced Hepatocellular Carcinoma. Ann Surg. 2022 Dec 1;276(6):e842-e850. doi: 10.1097/SLA.0000000000004866. Epub 2021 Mar 18.

    PMID: 33914466BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Blood Transfusion, AutologousControl Groups

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jian-Hong Zhong, MD

    Guangxi Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 10, 2016

First Posted

January 13, 2016

Study Start

January 5, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

CN(1)