Liver NeoplasmsNCT05164406
Impact of Blood Salvage Therapy on Outcomes After Oncologic Liver Surgery
An observational study of Liver Neoplasms, run by Université de Sherbrooke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Blood salvage therapy
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- Adult Oncologic liver surgery scheduled in our institution
Who cannot join
- Condition precluding consent for trial Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1G5N3
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Neoplasms
- Being tested
- Blood salvage therapy
- Keywords
- Blood salvage therapy, Oncologic liver surgery
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood salvage therapyProcedure or surgery
In the blood salvage group, blood is systematically given back when the minimal amount of blood loss required for reprocessing is met
| Study group | Role | What they receive |
|---|---|---|
| With blood salvage | Patients undergoing oncologic liver surgery with systematic use of blood salvage therapy Receives: Procedure: Blood salvage therapy | |
| Without blood salvage | Patients undergoing oncologic liver surgery without any blood salvage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Measured: 18 months
Overall survival
Measured: 18 months
Transfusion
Allogenic blood products requirements
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2018
- Primary completion1 Aug 2019
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Collin, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164406
- Sponsor's protocol ID
- 2018-2534
- Status last verified
- May 2023
- First submitted
- 7 Dec 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38666789
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood Salvage Therapy During Oncologic Liver Surgeries on Allogenic Transfusion Events, Survival and Recurrence
- ClinicalTrials.gov ID
- NCT05164406
- Acronym / sponsor ID
- 2018-2534
- Conditions
- Liver Neoplasms
- Keywords
- Blood salvage therapy, Oncologic liver surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With blood salvage | – | Procedure: Blood salvage therapyPatients undergoing oncologic liver surgery with systematic use of blood salvage therapy |
| Without blood salvage | – | –Patients undergoing oncologic liver surgery without any blood salvage therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Adult Oncologic liver surgery scheduled in our institution
Key exclusion criteria (1 listed)
- Condition precluding consent for trial Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood salvage therapyIn the blood salvage group, blood is systematically given back when the minimal amount of blood loss required for reprocessing is met | Procedure or surgery | With blood salvage |
Primary outcome
Recurrence free survival
Time frame: 18 months
Overall survival
Time frame: 18 months
Transfusion
Time frame: Up to 30 days after surgery
Allogenic blood products requirements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 38666789Lugassy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Collin, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.