Liver FailureSALTNCT06772298
Study of Oxidized Albumin in Liver Transplant Patients
An observational study of Liver Failure and Liver Cirrhosis, run by Region Stockholm.
Trial summary
The overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. This is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure, Liver Cirrhosis, Liver Transplant Disorder
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 31 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient that are accepted for liver transplantation and put on the waiting list will be included
Who may be able to join
- Patients on waiting list for liver transplantation
Who cannot join
- none
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Håkon Haugaa, MD, PhD contact
About this study
The overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. This is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. Samples for analysing the oxidation state of albumin, general oxidative damage and anti-oxidant state, the activation of the complement system and factors involved in coagulation will be obtained before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
- Conditions
- Liver Failure, Liver Cirrhosis, Liver Transplant Disorder
- Keywords
- Oxidised albumin, Complement, Coagulation
- Medical subject headings
- Liver Failure, Liver Cirrhosis, Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Albumin quality
Describe potential qualitative changes in albumin during the liver transplantation procedure. Non-oxidised, single oxidised and double oxidised albumin will be analysed by HPLC.
Measured: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Secondary outcomes (9)
Effect of clinical factors on albumin quality before transplantation
Explore the impact of different clinical factors on albumin's oxidative state before transplantation. For this a multiple regression model will be used including clinical parameters; sex (male or female), age (years), and MELD (Model for end-stage liver disease).
Measured: Before transplantation.
Effect of clinical factors on albumin quality after transplantation
Explore the impact of different clinical factors on albumin's oxidative state after transplantation. For this a multiple regression model will be used including clinical parameters; sex (male or female), age (years), MELD (Model for end-stage liver disease), bleeding during surgery (in liters), time of surgery (hours).
Measured: On postop days 1, 2 and about 30.
Graft outcome in relation to albumin quality
Explore of the oxidation state of albumin (percentage of albumin that is oxidised) is correlated with graft function (bilirubin levels in mg/L)
Measured: At days 1, 2 and about 30 days after transplantation
Oxidative stress in relation to albumin quality
Explore is the oxidation state of albumin (percentage of albumin oxidised) is related to a general oxidative state measured by TBARS (Thiobarbituric acid reactive substances) measured as MDA (malondialdehydes) in nmol/ml.
Measured: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Anti-oxidant capacity in relation to albumin quality
Explore is the oxidation state of albumin (percentage of albumin oxidised) is related to the total anti-oxidant capacity measured a the ability of the sample to reduce ferric ions (Fe3+) to ferrous ions (Fe2+) using a phenanthroline substance.
Measured: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Binding capacity
Explore whether the oxidation state of albumin (percentage of albumin oxidised) is affecting albumin's binding capacity measured by the ability of albumin in the sample to bind cobalt (mg/ml).
Measured: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Complement system
Explore how the complement system (C3bc in mg/ml) is affected during liver transplantation and how this is related to albumin quality (percentage of albumin oxidised)
Measured: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Complement system
Explore how the complement system (terminal complement complex in mg/ml) is affected during liver transplantation and how this is related to albumin quality (percentage of albumin oxidised)
Measured: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Coagulation
Explore how coagulation (Thrombin-antithrombin complex in microgram/ml) is affected during liver transplantation and how this is related to albumin quality (percentage albumin oxidised)
Measured: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772298
- Sponsor's protocol ID
- K 2024-3904
- Acronym
- SALT
- Status last verified
- May 2024
- First submitted
- 3 Jun 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data might be shared on special request of researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oxidized Albumin in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT06772298
- Acronym / sponsor ID
- SALT / K 2024-3904
- Conditions
- Liver Failure, Liver Cirrhosis, Liver Transplant Disorder
- Keywords
- Oxidised albumin, Complement, Coagulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jan 2025 (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 overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. This is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. Samples for analysing the oxidation state of albumin, general oxidative damage and anti-oxidant state, the activation of the complement system and factors involved in coagulation will be obtained before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient that are accepted for liver transplantation and put on the waiting list will be included
Key inclusion criteria (1 listed)
- Patients on waiting list for liver transplantation
Key exclusion criteria (1 listed)
- none
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
Albumin quality
Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Describe potential qualitative changes in albumin during the liver transplantation procedure. Non-oxidised, single oxidised and double oxidised albumin will be analysed by HPLC.
9 secondary outcomes
Effect of clinical factors on albumin quality before transplantation
Time frame: Before transplantation.
Effect of clinical factors on albumin quality after transplantation
Time frame: On postop days 1, 2 and about 30.
Graft outcome in relation to albumin quality
Time frame: At days 1, 2 and about 30 days after transplantation
Oxidative stress in relation to albumin quality
Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Anti-oxidant capacity in relation to albumin quality
Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Binding capacity
Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Complement system
Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Complement system
Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Coagulation
Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
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 13 Jan 2025.
- Individual participant dataSharing planned: Undecided. Data might be shared on special request of researchers
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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.
Håkon Haugaa, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure and Liver Cirrhosis, run by Region Stockholm.
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: opening soon, as of the sponsor's last update on 13 Jan 2025. 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?
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 Olav Rooijackers, PhD (0739661645, olav.rooyackers@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Albumin quality (time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.). 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 13 Jan 2025.