Impact of Blood Salvage Therapy on Outcomes After Oncologic Liver Surgery

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT05164406

Collaborator

(none)

106

Enrollment

Location

37.9

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Neoplasms	Procedure: Blood salvage therapy

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 Design

Study Type:

Observational

Actual Enrollment :

106 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Feb 28, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Recurrence free survival [18 months]
Overall survival [18 months]
Transfusion [Up to 30 days after surgery]
Allogenic blood products requirements

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

Adult Oncologic liver surgery scheduled in our institution

Exclusion Criteria:

Condition precluding consent for trial Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1G5N3

Sponsors and Collaborators

Université de Sherbrooke

Investigators

Principal Investigator: Yves Collin, MD, Université de Sherbrooke

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université de Sherbrooke

ClinicalTrials.gov Identifier:

NCT05164406

Other Study ID Numbers:

2018-2534

First Posted:

Dec 20, 2021

Last Update Posted:

Dec 20, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Université de Sherbrooke

Blood salvage therapy

Oncologic liver surgery

Additional relevant MeSH terms:

Liver Neoplasms

Study Results

No Results Posted as of Dec 20, 2021