Study of Oxidized Albumin in Liver Transplant Patients

Not yet recruiting

• Conditions: Liver Failure; Liver Cirrhosis; Liver Transplant Disorder

• Registration Number: NCT06772298
• Lead Sponsor: Region Stockholm

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-02-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients on waiting list for liver transplantation

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Albumin quality	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 Outcome Measures

Name	Time	Method
Oxidative stress in relation to albumin quality	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.
Effect of clinical factors on albumin quality before transplantation	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).
Graft outcome in relation to albumin quality	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)
Anti-oxidant capacity in relation to albumin quality	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.
Effect of clinical factors on albumin quality after transplantation	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).
Complement system	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)
Coagulation	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)
Binding capacity	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).