Study of Oxidized Albumin in Liver Transplant Patients

NCT06772298 | Not Yet Recruiting

• 1 other identifier: K 2024-3904
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Failure; Liver Cirrhosis; Liver Transplant Disorder

Keywords

Oxidised albumin; Complement; Coagulation

Outcome Measures

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.

  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

  Before transplantation.

• Effect of clinical factors on albumin quality after transplantation

  On postop days 1, 2 and about 30.

• Graft outcome in relation to albumin quality

  At days 1, 2 and about 30 days after transplantation

• 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.

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients on waiting list for liver transplantation

You may not qualify if:

• none

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples will be obtained

MeSH Terms

Conditions

Liver Failure; Liver Cirrhosis; Thrombosis

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Olav Rooijackers, PhD

CONTACT

0739661645; olav.rooyackers@ki.se

Håkon Haugaa, MD, PhD

CONTACT

hokan.haugaa@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 13, 2025

Record last verified: 2024-05