Association Between Autologous Transfusion and Recurrence-free Survival in Patients With HCC After Resection (AT/HCC)

Guangxi Medical University

Status: Completed

Conditions: Liver Cancer

Treatments: Other: Control group; Procedure: Autotransfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02654028

AT/HCC

Details and patient eligibility

About

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.

Full description

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?

Enrollment: 618 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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618 participants in 2 patient groups

Autotransfusion group

Experimental group

Description:

These group of patients will receive autotransfusion before liver resection.

Treatment:

Procedure: Autotransfusion

Control group

Active Comparator group

Description:

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

Treatment:

Other: Control group