ClinicalTrials.gg
Not yet recruitingNCT06772298SALTUpdated Jan 13, 2025

Study of Oxidized Albumin in Liver Transplant Patients

An observational study in Liver Failure, Liver Cirrhosis and Liver Transplant Disorder, sponsored by Region Stockholm. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Region Stockholm · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Liver Failure
  • Liver Cirrhosis
  • Liver Transplant Disorder

Keywords

  • Oxidised albumin
  • Complement
  • Coagulation
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In context

Liver Failure

190 studies on the registry are indexed under Liver Failure; 33 are open to participants now.

This study's planned enrollment of 10 is below the median of 129 across 66 observational studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient that are accepted for liver transplantation and put on the waiting list will be included

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients on waiting list for liver transplantation

Exclusion criteria

Exclusion Criteria:

  • none
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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).

    Time frame: Before transplantation.

  2. 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).

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

  3. 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)

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

  4. 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.

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

  5. 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.

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

  6. 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).

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

  7. 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)

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

  8. 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)

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

  9. 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)

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — Data might be shared on special request of researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06772298
Lead sponsor
Region Stockholm
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Feb 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 13, 2025

Study contacts

Olav Rooijackers, PhD
Contact
olav.rooyackers@ki.se
0739661645
Håkon Haugaa, MD, PhD
Contact
hokan.haugaa@regionstockholm.se

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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