RecruitingACTRN12619000386134

A search of novel biomarkers in detecting early allograft dysfunction afterliving donor liver transplantation

A lipidomics study in the early detection of early allograft dysfunction after living donor liver transplantation

Sponsor

Chang Gung Memorial Hospital

Enrollment

120 participants

Start Date

Oct 16, 2018

Study Type

Observational

Conditions

early allograft dysfunction living donor liver transplantation

Summary

Liver transplantation has become the ultimate treatment for patients with end-stage liver disease. EAD has a strong effect on graft failure and recipient mortality. In the study, we will examine the metabolomic differences between EAD and non-EAD patients among recipients of different etiologies. While EAD is defined as deterioration in the coagulation profiles and liver functions compared to non-EAD recipients on postoperative day 7, we expect to find earlier changes in the distribution of metabolites in EAD patients. A lipidomic study of their corresponding donors will also be conducted. Further in-depth metabolomic studies may reveal disturbances in the distribution of amino acid and lipids, providing potential biomarkers for the early detection of EAD.

Eligibility

Sex: Both males and femalesMin Age: 20 Yearss

Plain Language Summary

Simplified for easier understanding

Liver transplantation is life-saving, but in some patients the transplanted liver doesn't function well immediately after surgery — a complication called early allograft dysfunction (EAD). This study aims to find early biological markers (biomarkers) in the blood that might predict EAD before it becomes obvious in standard liver function tests. Researchers will analyse metabolites — small molecules produced by the body's chemical processes — in blood samples from liver transplant recipients and their donors. By comparing patients who develop EAD with those who don't, they hope to identify patterns that signal trouble earlier, potentially allowing doctors to intervene sooner. You may be eligible if you are a recipient of a living donor liver transplant enrolled consecutively over a three-year period at the study site. Patients in a serious infected or shock state before transplantation, or those with severe lung pressure problems, would not be included.

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Interventions

We plan to enroll 120 living liver donors and 120 corresponding recipients over a 3-year period (roughly 40 pairs per year). Demographic data including age, gender, blood type, serum bilirubin, albumin, prothrombin levels, international normalized ratio (INR), serum alanine aminotransferase (ALT) activity, serum aspartate amniotransferase (AST) activity, serum gamma-glutamyltransferase (GGT) activity, platelet count, cholesterol profile and Model for End-Stage Liver Disease (MELD) score will be collected. Sample collection Blood and urine samples will be collected from the donors pre-operatively and from recipients at 6 different time points as follows: (T1) before induction of general anesthesia as baseline, (T2) 20 minutes after the start of anhepatic phase, (T3) 2 hours post reperfusion, (T4) day 1 post-operatively (T5) day 3 post-operatively, and (T6) day 7 post-operatively. Bile samples will be extracted from donors and recipients from their gallbladders after being removed by the surgeons. Recipients’ remnant liver tissues will also be extracted before livers are to be sent to pathology laboratory. Hemodynamic data will also be collected at these time points. The blood will be centrifuged immediately at 1,000 g, 4 °C, for 10 minutes to obtain plasma. Samples were stored at -80 °C until batch analysis. The routine biochemical data will be measured by the clinical laboratory within the hospital.

Locations(1)

ROC, Taiwan, Province Of China

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ACTRN12619000386134