NCT05164406

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

December 7, 2021

Last Update Submit

May 29, 2023

Conditions

Liver Neoplasms

Keywords

Blood salvage therapyOncologic liver surgery

Outcome Measures

Primary Outcomes (3)

  • Recurrence free survival

    18 months

  • Overall survival

    18 months

  • Transfusion

    Allogenic blood products requirements

    Up to 30 days after surgery

Study Arms (2)

With blood salvage

Patients undergoing oncologic liver surgery with systematic use of blood salvage therapy

Procedure: Blood salvage therapy

Without blood salvage

Patients undergoing oncologic liver surgery without any blood salvage therapy

Interventions

Blood salvage therapyPROCEDURE

In the blood salvage group, blood is systematically given back when the minimal amount of blood loss required for reprocessing is met

With blood salvage

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Adult Oncologic liver surgery scheduled in our institution

You may not qualify if:

  • Condition precluding consent for trial Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1G5N3, Canada

Location

Related Publications (1)

  • Lugassy L, Marion S, Balthazar F, Cheng Oviedo SG, Collin Y. Impact of blood salvage therapy during oncologic liver surgeries on allogenic transfusion events, survival, and recurrence: an ambidirectional cohort study. Int J Surg. 2024 Jun 1;110(6):3392-3400. doi: 10.1097/JS9.0000000000001458.

    PMID: 38666789DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Officials

  • Yves Collin, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 20, 2021

Study Start

January 1, 2018

Primary Completion

August 1, 2019

Study Completion

February 28, 2021

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)