Impact of Blood Salvage Therapy on Outcomes After Oncologic Liver Surgery

May 29, 2023 updated by: Université de Sherbrooke

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G5N3
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing liver surgery for any cancer in our institution between january 2018 and August 2019 (blood salvage group) and patients who underwent liver surgery without blood salvage between 2011 and 2018 (control group)

Description

Inclusion Criteria:

  • Adult Oncologic liver surgery scheduled in our institution

Exclusion Criteria:

  • Condition precluding consent for trial Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
With blood salvage
Patients undergoing oncologic liver surgery with systematic use of blood salvage therapy
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
Without blood salvage
Patients undergoing oncologic liver surgery without any blood salvage therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 18 months
18 months
Recurrence free survival
Time Frame: 18 months
18 months
Transfusion
Time Frame: Up to 30 days after surgery
Allogenic blood products requirements
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: Yves Collin, MD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-2534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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