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NCT05164406 Clinical Trial

Impact of Blood Salvage Therapy on Outcomes After Oncologic Liver Surgery

Liver Neoplasms Clinical Trial

Official title:
Impact of Blood Salvage Therapy During Oncologic Liver Surgeries on Allogenic Transfusion Events, Survival and Recurrence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05164406
Other study ID # 2018-2534
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date February 28, 2021

Study information
Verified date May 2023
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A before and after trial comparing the systematic use of blood salvage therapy with leucocyte filter during oncologic liver resections. Recurrence, survival, allogenic transfusion rates and surgical outcomes are compared with a representative historic cohort.

Description:

Blood salvage therapy in oncologic liver surgery is seldom used based on unproven concerns about the safety of the technique regarding potential cancer dissemination or recurrence. Nevertheless, the technique has proven advantages in other surgical settings regarding the allogenic transfusion outcomes. Allogenic blood transfusion has been scientifically proven to worsen prognosis in oncologic surgery. This study compares a cohort of patients systematically exposed the blood salvage therapy to one comparable cohort without the therapy and outcomes regarding transfusion rates, post-operative Hb measurement, recurrence, overall survival, and post-operative adverse events.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date February 28, 2021
Est. primary completion date August 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Adult Oncologic liver surgery scheduled in our institution Exclusion Criteria: - Condition precluding consent for trial Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood salvage therapy
In the blood salvage group, blood is systematically given back when the minimal amount of blood loss required for reprocessing is met

Locations
Country Name City State
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec

Sponsors (1)
Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence free survival 18 months
Primary Overall survival 18 months
Primary Transfusion Allogenic blood products requirements Up to 30 days after surgery
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