Liver TransplantNCT06215404
Fluid Management Strategies on Blood Loss in Liver Transplantation
A study testing Liberal group and restrictive group in people with Liver Transplant, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Liberal group and restrictive group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- end stage liver disease
- age between 18y/o to 75 y/o
- expected to recieve to receive liver transplantation
Who cannot join
- arrythmia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Kuang-Cheng Chan
About this study
Official title: Effects of Different Fluid Management Strategies on Blood Loss, Inflammatory Response, and Major Organ Sequelae in Liver Transplantation
During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Infusion management to reduce bleeding is a very important issue in liver transplant surgery. Restrictive infusion management can effectively reduce the amount of bleeding in liver transplantation, but it remains unclear whether it will cause sequelae in other major organs.
The investigators plan to study different infusion goals and strategies in liver transplant surgery using a randomized group model, using the PiCCO (Pulse Contour Cardiac Output) cardiopulmonary volume monitor, and setting the stroke volume variation (SVV) as the macroscopic circulation.The purpose of this study was to divide it into restrictive and liberal groups to explore the impact on liver transplantation bleeding volume and inflammatory response as well as postoperative lung and renal function, and to collect statistics on clinical care and postoperative sequelae (pulmonary liver, renal function impairment, etc.) in order to develop the most appropriate infusion management strategy in liver transplantation.
- Conditions
- Liver Transplant
- Being tested
- Liberal group, restrictive group
- Keywords
- fluid management, blood loss
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal groupOther
Fluid challage to keep stroke volume variation < 10%
restrictive groupOther
Fluid challage to keep stroke volume variation < 18%
| Study group | Role | What they receive |
|---|---|---|
| Liberal group | Active comparator | stroke volume variation < 10% Receives: Other: Liberal group |
| restrictive group | Experimental | stroke volume variation < 18% Receives: Other: restrictive group |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss intraoperatively
blood loss intraoperatively in liver transplant
Measured: during the operation
Secondary outcomes (3)
Lung injury biomarker
serum Clara Cell Protein (CC16)
Measured: from biginning of the operation to postoprative day 1
Kidney injury biomarker
serum Neutrophil Gelatinase Associated Lipocalins (NGALs)
Measured: from biginning of the operation to postoprative day 1
Influammatory reponses
IL-6
Measured: from biginning of the operation to postoprative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start15 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-Cheng Chan, M.D.,PhD., Principal investigator, Department of Anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215404
- Sponsor's protocol ID
- 202308015MINC
- Status last verified
- Apr 2025
- First submitted
- 10 Jan 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Fluid Management Strategies on Blood Loss, Inflammatory Response, and Major Organ Sequelae in Liver Transplantation
- ClinicalTrials.gov ID
- NCT06215404
- Acronym / sponsor ID
- 202308015MINC
- Conditions
- Liver Transplant
- Keywords
- fluid management, blood loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jan 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.
During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Infusion management to reduce bleeding is a very important issue in liver transplant surgery. Restrictive infusion management can effectively reduce the amount of bleeding in liver transplantation, but it remains unclear whether it will cause sequelae in other major organs.
The investigators plan to study different infusion goals and strategies in liver transplant surgery using a randomized group model, using the PiCCO (Pulse Contour Cardiac Output) cardiopulmonary volume monitor, and setting the stroke volume variation (SVV) as the macroscopic circulation.The purpose of this study was to divide it into restrictive and liberal groups to explore the impact on liver transplantation bleeding volume and inflammatory response as well as postoperative lung and renal function, and to collect statistics on clinical care and postoperative sequelae (pulmonary liver, renal function impairment, etc.) in order to develop the most appropriate infusion management strategy in liver transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal group | Active comparator | Other: Liberal groupstroke volume variation < 10% |
| restrictive group | Experimental | Other: restrictive groupstroke volume variation < 18% |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- end stage liver disease
- age between 18y/o to 75 y/o
- expected to recieve to receive liver transplantation
Key exclusion criteria (1 listed)
- arrythmia
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 |
|---|---|---|
| Liberal groupFluid challage to keep stroke volume variation < 10% | Other | Liberal group |
| restrictive groupFluid challage to keep stroke volume variation < 18% | Other | restrictive group |
Primary outcome
blood loss intraoperatively
Time frame: during the operation
blood loss intraoperatively in liver transplant
3 secondary outcomes
Lung injury biomarker
Time frame: from biginning of the operation to postoprative day 1
Kidney injury biomarker
Time frame: from biginning of the operation to postoprative day 1
Influammatory reponses
Time frame: from biginning of the operation to postoprative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- 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.
Kuang-Cheng Chan, M.D.,PhD. principal investigator
Department of Anesthesiology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal group and restrictive group in people with Liver Transplant, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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: looking for participants now, as of the sponsor's last update on 11 Apr 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kuang-Cheng Chan, M.D.,PhD. (+886-2-23123456 ext. 262158, jkjchan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss intraoperatively (time frame: during the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.