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Liver Transplantation clinical trials

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NCT ID: NCT06418893 Recruiting - Clinical trials for Liver Transplant Recipients

Effect of TCI Propofol on Liver Transplant (TCI) Propofol on Intra-operative Usage of Vasopressors in Liver Transplant Recipients.

Start date: August 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Both isoflurane and propofol are being used to give anaesthesia for living donor liver transplant in our institute. Propofol when compared to isoflurane has advantages like early awakening from anaesthesia, reduced nausea, vomiting in the postoperative period. Propofol also has antioxidant properties. Because of its antioxidant properties propofol may have a protective effect against oxidative stress and ischemia reperfusion injury in major organs during liver transplant surgery. However, there are no studies showing the effect of isoflurane and propofol on Intraoperative hemodynamics and postoperative liver and kidney functions.Thus, we are conducting this study to know the effect of these agents on intraoperative hemodynamics and postoperative liver and kidney function.

NCT ID: NCT06400771 Recruiting - Clinical trials for Liver Transplant; Complications

Safety of DNP007 in Healthy Subjects

Start date: May 23, 2024
Phase:
Study type: Observational

This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number.

NCT ID: NCT06386198 Recruiting - Pediatric ALL Clinical Trials

HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients

HEAL-Tx:ToC
Start date: March 3, 2024
Phase: N/A
Study type: Interventional

The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.

NCT ID: NCT06382740 Recruiting - Clinical trials for Liver Transplantation

Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years

Over70-LT
Start date: October 1, 2022
Phase:
Study type: Observational

Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process. This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.

NCT ID: NCT06342557 Recruiting - Liver Transplant Clinical Trials

Transitional ePRO Diary Liver

MACROLIVER
Start date: March 28, 2024
Phase:
Study type: Observational

The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients.

NCT ID: NCT06302205 Recruiting - Clinical trials for Liver Transplantation

A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity

PHOENIX-L
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator. At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness. To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase.

NCT ID: NCT06263114 Recruiting - Clinical trials for Liver Transplant; Complications

Correlation of Blood Gene Expression (TruGraf Liver) With Liver Biopsy in Pediatric Liver Transplant Recipients

Start date: January 1, 2024
Phase:
Study type: Observational

Liver transplant rejection is when the body's immune system attacks and damages the liver of a transplant recipient. Currently the best way to see if that is happening is with a liver biopsy. The purpose of this research study is to see if a simple blood test can diagnose if a transplanted liver is being rejected.

NCT ID: NCT06236568 Recruiting - Clinical trials for Hepatocellular Carcinoma

Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation

Start date: February 6, 2024
Phase: N/A
Study type: Interventional

The use of devices for liver grafts perfusion before transplantation, either hypothermic (HOPE) or normothermic (NMP), is rapidly spreading thanks to the promising results obtained so far in terms of graft survival and post-operative morbidity. Besides the well-established ability to increase the rate of transplantability of extended criteria donors (ECD) and donors after cardiac death (DCD), the use of machine perfusion (MP) may also improve the oncological outcomes of patients affected by hepatocellular carcinoma (HCC) undergoing liver transplantation (LT). The underlying mechanism is represented by the modulation of the ischemia-reperfusion injury (IRI)-related cellular damage obtained by the liver graft perfusion with HOPE before LT. The identification of biomarkers able to predict graft outcomes and highlight the mechanism of graft injury before transplantation rapidly and in non-invasive manner is therefore needed. Mass spectrometry-based metabolomics has already shown its potential by using perfusion liquids or pre-implantation biopsies. The aim of the investigators is to run an open-label, randomised, controlled trial to study the impact of treating standard liver grafts from brain dead donors (DBD) with HOPE before liver transplant in patients affected by HCC. Patients aged 18-75 years presenting with HCC Milan-in at listing will be considered for inclusion. Presence of extra-hepatic disease and general contraindications to liver transplantation as defined by the local tumor board are considered as exclusion criteria. Eligible patients will be randomly assigned (1:1) with the use of a dedicated software to MP (intervention group) or no-MP (control group) before liver transplantation. Untargeted mass spectrometry metabolomics (UHPLC-HRMS) will be performed on liver graft perfusate, liver graft biopsy and recipient blood samples, to identify by classification methods, novel predictive markers of IRI. Furthermore, rapid targeted MS approaches will be performed on VIP metabolites and known key compounds (such as TCA, aminoacids, energy metabolism) to rapidly assess graft function as well as post-operative outcome. Blood samples of the recipient will be collected at two checkpoints (listing, and 3 months after liver transplant) to evaluate exosomes and miRNA expression fluctuations (liquid biopsy). Primary outcomes of the study will be overall survival, graft survival and recurrence-free survival at 1- and 2-years. Survival results will be compared to those expected based on the Metroticket 2.0 score to assess the impact of MP in reducing the risk of HCC recurrence. Patients will remain in follow-up as for clinical practice to assess 3- and 5-years survival. Secondary end-point will be to define liquid biopsy efficacy to predict HCC recurrence and to define the correlation between metabolomic observations and HCC recurrence pattern.

NCT ID: NCT06225206 Recruiting - Clinical trials for Liver Transplant Failure

Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients

Start date: July 1, 2021
Phase:
Study type: Observational

Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.

NCT ID: NCT06217965 Recruiting - Clinical trials for Liver Transplantation

Evaluation of the Epidemiological and Psychosocial Outcomes of Liver Graft Recipients Transplanted During Childhood

EPsyGraft
Start date: January 1, 2024
Phase:
Study type: Observational

The main objective of this study is to better characterize the adult population with a history of liver transplantation in pediatric age. In this context, the investigators will use a questionnaire to assess the participants social environment and lifestyle habits and validated scales to assess their alcohol consumption and anxiety levels. Secondly, the investigators would like to assess the participants knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication.