Liver Transplant; ComplicationsNCT06307158
Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation
An observational study of Liver Transplant; Complications, run by Zhejiang University.
Trial summary
The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplant; Complications
- How many people
- 998 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective review was conducted on the prospectively maintained liver transplantation database of the CLTR. The initial data collection included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020.
Who may be able to join
- adult-to-adult deceased donor liver transplantation for hepatocellular carcinoma
Who cannot join
- patients under 18 years of age
- presence of extrahepatic metastasis
- combined kidney transplantation
- reduced-size or split liver transplantation
- re-transplantation
About this study
The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis.
- Conditions
- Liver Transplant; Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative blood salvage and autotransfusion (IBSA) group | The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria included: patients under 18 years of age, presence of extrahepatic metastasis, combined kidney transplantation, reduced-size or split liver transplantation, re-transplantation, and missing data on analyzed variables. The remaining recipients were 349 in IBSA group who received salvaged blood autotransfusion during the LT. | |
| non-intraoperative blood salvage and autotransfusion (non-IBSA) group | The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria was as mentioned ahead. Recipients who did not receive salvaged blood autotransfusion during the LT were enrolled in non-IBSA group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recurrence of liver cancer
The overall incidence of HCC recurrence (intrahepatic or extrahepatic) after LT.
Measured: 2015.1.1-2020.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jan 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 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 Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307158
- Sponsor's protocol ID
- CT2024-ZJU-OBS1
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang M, Wei X, Shu W, Zhai X, Zhou Z, Cai J, Yang J, Jin B, Zheng S, Xu X. Influence of intraoperative blood salvage and autotransfusion on tumor recurrence after deceased donor liver transplantation: a large nationwide cohort study. Int J Surg. 2024 Sep 1;110(9):5652-5661. doi: 10.1097/JS9.0000000000001683.
PubMed 38847771
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intraoperative Blood Salvage and Autotransfusion on Tumor Recurrence After Deceased Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT06307158
- Acronym / sponsor ID
- CT2024-ZJU-OBS1
- Conditions
- Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Mar 2024 (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.
The practice of intraoperative blood salvage and autotransfusion (IBSA) during deceased donor liver transplantation (DDLT) for hepatocellular carcinoma (HCC) can potentially reduce the need for allogeneic blood transfusion. However, implementing IBSA remains debatable due to concerns about its possible detrimental effects on oncologic recurrence. Hence, a nationwide multi-center study was conducted to investigate further the association between IBSA and post-transplant HCC recurrence, including a stratified subgroup analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative blood salvage and autotransfusion (IBSA) group | – | –The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria included: patients under 18 years of age, presence of extrahepatic metastasis, combined kidney transplantation, reduced-size or split liver transplantation, re-transplantation, and missing data on analyzed variables. The remaining recipients were 349 in IBSA group who received salvaged blood autotransfusion during the LT. |
| non-intraoperative blood salvage and autotransfusion (non-IBSA) group | – | –The study included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020. Exclusion criteria was as mentioned ahead. Recipients who did not receive salvaged blood autotransfusion during the LT were enrolled in non-IBSA group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective review was conducted on the prospectively maintained liver transplantation database of the CLTR. The initial data collection included patients who underwent adult-to-adult DDLT for HCC in China between January 2015 and December 2020.
Key inclusion criteria (1 listed)
- adult-to-adult deceased donor liver transplantation for hepatocellular carcinoma
Key exclusion criteria (5 listed)
- patients under 18 years of age
- presence of extrahepatic metastasis
- combined kidney transplantation
- reduced-size or split liver transplantation
- re-transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative recurrence of liver cancer
Time frame: 2015.1.1-2020.12.31
The overall incidence of HCC recurrence (intrahepatic or extrahepatic) after LT.
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 12 Mar 2024.
- Derived from this study: PubMed 38847771Yang M, Wei X, Shu W, Zhai X, Zhou Z, Cai J, Yang J, Jin B, Zheng S, Xu X. Influence of intraoperative blood salvage and autotransfusion on tumor recurrence after deceased donor liver transplantation: a large nationwide cohort study. Int J Surg. 2024 Sep 1;110(9):5652-5661. doi: 10.1097/JS9.0000000000001683.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by Zhejiang University.
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 5 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative recurrence of liver cancer (time frame: 2015.1.1-2020.12.31). 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 NCT06307158, 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 12 Mar 2024.