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Liver Transplantation clinical trials

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NCT ID: NCT06290154 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Factors Associated With Posttransplant Cardiac Outcomes

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

Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant.

NCT ID: NCT06280950 Not yet recruiting - Liver Transplant Clinical Trials

Expanding Liver Transplant Immunosuppression Minimization Via Everolimus

ELIMINATE
Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months.

NCT ID: NCT06279884 Not yet recruiting - Clinical trials for Liver Transplantation

A Cohort Study on the Pathogen Spectrum of Liver Transplant Recipients Complicated With Infection

Start date: March 2024
Phase:
Study type: Observational

The goal of this observational study is to map the pathogen profile of secondary infections in liver transplant recipients, to correlate the basic immune status with the characteristics of the secondary infection pathogen profile, and to establish an early warning system for monitoring secondary infections, so as to explore safe and effective therapeutic modalities to further reduce the morbidity and mortality of liver failure. The main questions it aims to answer are: - Characterize the distribution of pathogenic bacteria infecting liver transplant recipients. - Establish a monitoring and early warning system for secondary infections.

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: NCT06257407 Not yet recruiting - Clinical trials for Liver Transplant; Complications

Perioperative Hemostasis Management in Liver Transplantation

HEMOTRANSPLANT
Start date: March 1, 2024
Phase:
Study type: Observational

Liver transplantation (LT) is a surgery with risk of bleeding. Several risk factors have been identified: complex dissection, portal hypertension, history of ascites fluid infections, history of surgical procedures, pre-existing complex hemostatic disorders and those acquired during the procedure. Diffuse bleeding can occur at any time during the 3 phases of surgery: dissection, anhepatic and neohepatic. However, intraoperative bleeding and transfusion requirements remain difficult to predict. Current predictive models are based in particular on preoperative characteristics and do not take into account the course and different phases of the operation. The need for transfusions has largely decreased over the last 20 years, and currently around 20-25% of patients are transfused (transfusion of at least 1 blood product during LT). However, massive transfusion is necessary in 10% of LT. The European Society of Anaesthesiology (ESA) has issued recommendations on the management of severe bleeding during surgery. However, these recommendations are not specific to LT. Moreover, transfusion strategies vary widely from one center to another. The implementation of protocols within teams dedicated to LT has led to a reduction in bleeding and transfusion, with or without the use of viscoelastic testing. Intraoperative bleeding and transfusion requirements, as well as postoperative thromboembolic complications, remain difficult to predict. Predictive models of bleeding risk have been developed, but they are based solely on preoperative characteristics and do not take into account the course and various phases of the operation. In addition, new methods such as Bayesian inference or machine learning have been developed, and seem capable of providing different information from that obtained by conventional models. The overall aim of this prospective multicenter observational study is to investigate the risk factors for bleeding and thrombosis in per- and post-operative LT using different predictive methods, and to describe the management of bleeding and post-operative anticoagulation in metropolitan France.

NCT ID: NCT06254248 Not yet recruiting - Liver Transplant Clinical Trials

Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma

IMMUNO-TH
Start date: May 15, 2024
Phase: Phase 2
Study type: Interventional

The prognosis of liver transplanted (LT) patients with recurrence of hepatocellular carcinoma (HCC), especially those with progression after locoregional treatment or advanced HCC, remains poor. Current treatment modalities involve tyrosine kinase inhibitors (TKIs) characterized by a low response rate and often poor tolerability. Encouraging findings from the Imbrave 150 study, demonstrating increased survival rates coupled with favorable treatment tolerance, prompt the investigators to consider the potential of offering the combination of treatment with Atezolizumab-Bevacizumab (Atezo-Beva) to patients with LT. No data regarding the safety and efficacy of this new combination are available for patients with LT as they were not included in Imbrave 150. Immunosuppression after LT is low when compared to essentially all other organ recipients, liver recipients are considered with lower immunological risk. However, the use of ICIs has been associated with a risk of hepatic rejection in LT patients. In this study, in order to prevent acute cellular rejection (ACR) occurrence, we propose to adopt a standardized immunosuppressive regimen closed to the one used immediately after LT but with lower therapeutic goals for tacrolimus and everolimus to allow immunotherapy treatment to be effective. The better tolerance of liver grafts will probably lead to less risk of rejection with Atezo-Beva than in other organ transplants.

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: NCT06222554 Not yet recruiting - Kidney Transplant Clinical Trials

Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the feasibility of the MoveMend Health software program as an integrated supplement to traditional acute care/in-hospital occupational therapy for patients following liver and kidney transplants, as determined by recruitment rates, program completion, intervention adherence, safety incidence, and patient feedback on device/program performance.

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.