An observational study in Liver Transplantation (LT), Immuno-suppression and Biomarkers / Blood, sponsored by Hospital Italiano de Buenos Aires. Recruiting at 3 sites in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Hospital Italiano de Buenos Aires · Observational
This multicenter prospective observational study will evaluate immune biomarkers in adults undergoing liver transplantation. The study aims to describe how immune markers change before and after transplantation and to assess whether these changes are associated with complications such as infections, acute cellular rejection, and viral reactivation during the first year after transplantation.
Blood samples will be collected before transplantation, on days 0, 3, and 7 after transplantation, and at months 1, 3, 6, and 12. Biomarkers evaluated will include cytokines, interferons, immunoglobulins, lymphocyte populations, monocyte HLA-DR, neutrophil CD64, functional immune assays, checkpoint molecules, and Torque Teno Virus. Clinical outcomes will be recorded prospectively. Biomarker results will be used for research purposes only and will not modify immunosuppressive treatment or other clinical decisions.
This is a multicenter, observational, analytical, prospective cohort study conducted at three liver transplant centers in Buenos Aires, Argentina: Hospital Italiano de Buenos Aires, Hospital Universitario Austral, and Hospital Alemán de Buenos Aires.
The study will include 60 adult liver transplant recipients. Serial blood samples will be obtained before transplantation and on days 0, 3, and 7, as well as at months 1, 3, 6, and 12 after transplantation. Early immune profiling will include pro-inflammatory and anti-inflammatory cytokines and interferons. Additional immune markers include immunoglobulins, lymphocyte populations, monocyte HLA-DR expression, neutrophil CD64, ex vivo lipopolysaccharide-stimulated TNF-alpha production, checkpoint molecules, and Torque Teno Virus.
Participants will be followed prospectively for clinical outcomes including infections, acute cellular rejection, hospitalizations, and viral reactivations. The study will evaluate longitudinal biomarker trajectories and their association with these clinical outcomes, including their potential diagnostic and predictive performance.
All biomarker measurements are performed for research purposes only. Results will not be used to guide or modify immunosuppressive therapy, which will remain under the responsibility of the treating clinical team.
55 studies on the registry are indexed under Rejection, Psychology; 29 are open to participants now.
This study's planned enrollment of 60 is below the median of 184 across 27 observational studies indexed under Rejection, Psychology.
Browse Rejection, Psychology studies →Hospital Italiano de Buenos Aires is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
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Adult liver transplant recipients treated at Hospital Italiano de Buenos Aires, Hospital Universitario Austral, or Hospital Alemán de Buenos Aires.
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.
Age 18 years or older. Adult patients admitted to the intensive care unit after liver transplantation.
Exclusion Criteria:
Refusal to participate in the study. Liver transplantation performed for acute liver failure (fulminant hepatitis).
Liver transplant recipients with immune-mediated liver disease.
Other: Immune Biomarker Assessment
Liver transplant recipients with non-immune-mediated liver disease.
Other: Immune Biomarker Assessment
Serial measurement of immune biomarkers in blood samples collected before liver transplantation and on days 0, 3, and 7 and months 1, 3, 6, and 12 after transplantation. Biomarkers include cytokines, interferons, immunoglobulins, lymphocyte populations, monocyte HLA-DR, neutrophil CD64, functional immune assays, checkpoint molecules, and Torque Teno Virus. All measurements are performed for research purposes only and do not modify clinical management or immunosuppressive treatment.
Longitudinal Change in Early Serum Cytokine and Interferon Concentrations
Change over time in serum concentrations of IL-1β, IL-6, IL-8, IL-12, IL-17A, IL-18, TNF-α, MCP-1, IFN-α2, IFN-γ, IL-10, and TGF-β, comparing liver transplant recipients with immune-mediated versus non-immune-mediated liver disease. Concentrations will be measured in pg/mL. Analyses will be adjusted for the immunosuppressive regimen at each time point, including drug type, dose, and tacrolimus trough concentration.
Time frame: Pre-transplant and days 0, 3, and 7 after liver transplantation
Longitudinal Change in Immunoglobulin Levels and Leukocyte Profile
Change over time in serum immunoglobulin concentrations and leukocyte profile during the first year after liver transplantation, comparing recipients with immune-mediated versus non-immune-mediated liver disease. Analyses will be adjusted for the immunosuppressive regimen at each time point, including drug type, dose, and tacrolimus trough concentration.
Time frame: Months 1, 3, 6, and 12 after liver transplantation
Occurrence of Post-Transplant Infections
Occurrence of infections after liver transplantation and their association with longitudinal immune biomarker measurements to evaluate predictive performance.
Time frame: During index hospitalization, 0-3 months, and 3-12 months after liver transplantation
Diagnostic Performance of HLA-DR and CD64 for Bacterial Infection
Diagnostic performance of monocyte HLA-DR and neutrophil CD64 for distinguishing bacterial from non-bacterial infections in liver transplant recipients with suspected infection. Performance will be assessed using ROC curves, AUC, predictive values, and likelihood ratios.
Time frame: During the first 12 months after liver transplantation
Occurrence of Acute Cellular Rejection
Occurrence of acute cellular rejection and its association with longitudinal immune biomarker measurements during the first year after liver transplantation.
Time frame: Up to 12 months after liver transplantation
Occurrence of CMV and Other Herpesvirus Reactivation
Occurrence of CMV or other herpesvirus reactivation and its association with cellular and humoral biomarkers, including NK cells, regulatory T cells, immunoglobulins, and leukocyte profile.
Time frame: Up to 12 months after liver transplantation
Association of Torque Teno Virus Levels With Infection, Rejection, and Tacrolimus Exposure
Association of Torque Teno Virus (TTV) levels with the occurrence of infection and acute rejection, and longitudinal association between TTV levels and tacrolimus concentrations as a marker of immunosuppression.
Time frame: Months 1, 3, 6, and 12 after liver transplantation
Association Between Immunosuppression Intensity and Longitudinal Immune Biomarker Trajectories
Association between immunosuppression intensity, defined by immunosuppressive regimen, drug doses, and tacrolimus trough concentrations, and longitudinal trajectories of immune biomarkers. The analysis will explore whether this association differs according to immune-mediated versus non-immune-mediated liver disease.
Time frame: From transplantation through 12 months after liver transplantation
Plan to share: No — Individual participant data will not be shared because study data are coded, stored with restricted access, and managed in accordance with institutional confidentiality and data protection requirements.
Started Mar 2026 (actual). Primary completion is estimated for Apr 2027, 13 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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