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NCT Number: NCT06772298

Study of Oxidized Albumin in Liver Transplant Patients

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.

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Key information

Conditions

Liver Failure Cardiovascular Diseases Digestive System Diseases Embolism and Thrombosis Fibrosis Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Transplant Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients on waiting list for liver transplantation

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effect of clinical factors on albumin quality before transplantation

    Time frame: 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).

  2. Effect of clinical factors on albumin quality after transplantation

    Time frame: On postop days 1, 2 and about 30.

    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).

  3. Graft outcome in relation to albumin quality

    Time frame: At days 1, 2 and about 30 days after transplantation

    Explore of the oxidation state of albumin (percentage of albumin that is oxidised) is correlated with graft function (bilirubin levels in mg/L)

  4. 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.

    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.

  5. 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.

    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.

  6. Binding capacity

    Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.

    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).

  7. Complement system

    Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.

    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)

  8. Complement system

    Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.

    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)

  9. Coagulation

    Time frame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Håkon Haugaa, MD, PhD

CONTACT

[email protected]

Olav Rooijackers, PhD

CONTACT

[email protected]

0739661645

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Acronym: SALT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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