AGRA Before and After Liver Transplantation

NCT03446521 | Active Not Recruiting

• 1 other identifier: AGRA-TX
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The immune system is impaired in liver cirrhotic patients, which is associated with a high risk for bacterial infections and worse outcome. A novel biomarker, acellular growth retardation ability (AGRA), can predict the development of severe infections in patients with liver cirrhosis and therefore identify patients at risk. It is still unclear, how this biomarker develops after liver transplantation and how valid its predictions are for post-operative infections. Therefore, AGRA will be measured before and after liver transplantation and predictive merit of AGRA for post-transplant infections will be tested.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change of Acellular growth retardation ability (AGRA)

  Functional biomarker for the state of the humoral immune system

  change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation

Secondary Outcomes (5)

• Infections

  1 year after transplantation

• Infections

  1 year before transplantation

• Complications

  during hospital stay

• C reactive protein

  change from transplantation to 90 days after the end of prophylactic antibiotic treatment after the transplantation

• Liver function

  before transplantation

Study Arms (2)

Test group

Patients undergoing liver transplantation, no intervention (study-specific) is planed

Control Group

Respective organ donors of the included liver recipients, no intervention (study-specific) is planed

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients listed for liver transplantation at the University Hospital in Graz, Austria for any reason will be included in the study. The respective donors will serve as a control cohort.

You may qualify if:

• Patients between 18-80 years
• Listed for liver transplantation (for recipients)
• Liver recipient is included in the study (for donors)
• Informed consent

You may not qualify if:

• Antibiotic therapy with substances active against E. coli at the scheduled blood sampling

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Internal Medicine, Medical University of Geraz

Graz, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 26, 2018
• Study Start: July 6, 2018
• Primary Completion: May 31, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2024-11

Locations

AU (1)