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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02654028
Acronym
AT/HCC
Enrollment
618
Registered
2016-01-13
Start date
2019-01-05
Completion date
2021-12-30
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer

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.

Detailed 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?

Interventions

These group of patients will receive autotransfusion before liver resection.

OTHERControl group

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

Sponsors

Guangxi Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with tumor recurrence1-yearThe 1-year tumor recurrence will be compared between the two groups

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026