Skip to content

Study of Oxidized Albumin in Liver Transplant Patients

Study of Oxidized Albumin in Liver Transplant Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06772298
Acronym
SALT
Enrollment
10
Registered
2025-01-13
Start date
2025-02-01
Completion date
2026-12-31
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Liver Failure, Liver Transplant Disorder

Keywords

Oxidised albumin, Complement, Coagulation

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.

Interventions

None listed

Sponsors

Karolinska Institutet
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients on waiting list for liver transplantation

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Albumin qualityBefore 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

MeasureTime frameDescription
Effect of clinical factors on albumin quality after transplantationOn 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).
Graft outcome in relation to albumin qualityAt days 1, 2 and about 30 days after transplantationExplore of the oxidation state of albumin (percentage of albumin that is oxidised) is correlated with graft function (bilirubin levels in mg/L)
Oxidative stress in relation to albumin qualityBefore 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 transplantationBefore 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).
Binding capacityBefore 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).
Complement systemBefore 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)
CoagulationBefore 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)
Anti-oxidant capacity in relation to albumin qualityBefore 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.

Contacts

Primary ContactOlav Rooijackers, PhD
olav.rooyackers@ki.se0739661645
Backup ContactHåkon Haugaa, MD, PhD
hokan.haugaa@regionstockholm.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026