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Liver Transplantation clinical trials

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NCT ID: NCT04511429 Recruiting - Cancer Clinical Trials

COVID-19 in Immunosuppressed Children

Start date: June 30, 2020
Phase:
Study type: Observational [Patient Registry]

Viral respiratory infections are common infectious complications after kidney transplantation, especially in the pediatric age group, and immunosuppressed patients may develop more severe disease. Immunosuppressive medications alter the patient's immune response by acting on humoral, cellular immunity and neutrophil function, increasing the risk of serious viral infections. Little is known about how these patients respond to infection by the new coronavirus (SARS-CoV-2). Experience with SARS caused by the Influenza H1N1 virus suggests that the severity of the disease depends on pre-existing comorbidities and the individual immune response. In more severe cases, an imbalance between the inflammatory system and the immune system is observed, determining direct consequences when pro and anti-inflammatory cytokines reach the systemic circulation in an exacerbated and unbalanced manner. Such fact can generate "cytokine storm syndrome", resulting in multiple organ dysfunction syndrome. March 2020 reports from Papa Giovanni XXIII Hospital in Bergamo, Italy - one of the largest pediatric liver transplant centers - showed that the number of transplant patients infected with Coronavirus disease 2019 (COVID- 19) increased progressively. However, they did not see greater severity and complications in this population. Immunosuppression could act as a protective factor. The present study aims to describe the prevalence of viral infection by SARS-CoV-2 in a sample of immunosuppressed children, from three groups: kidney transplants, liver transplants and oncohematological. The investigators will also look for the epidemiological profile and clinical evolution of these patients, enabling a better understanding of the COVID-19 in this special population. The investigators' hypothesis is that infection with the new coronavirus may be asymptomatic in a large number of children and that immunosuppression, observed in liver and kidney transplant patients and also seen in cancer patients, may act as protection for severe forms of COVID-19. After obtaining written informed consent from the family, the investigators will include patients from 0-18 years of age, on regular outpatient follow-up, symptomatic or not, and will check for the presence of IgM/IgG antibodies against the SARS-CoV-2. For those symptomatic or with a positive IgM result, material (oro/nasopharyngeal swabs) for RT-PCR trial for the new coronavirus will be collected. Demographic and clinical variables will be registered. The outcomes are: Serology for COVID-19 result; PCR for COVID-19 result; presence of symptoms of COVID-19; proportion of patients with viral shedding on days 3,7,14,21 and 30 after diagnosis; need for hospital admission; need for Intensive care admission; death.

NCT ID: NCT04506398 Recruiting - Clinical trials for Liver Transplant; Complications

Heterogeneity and Evolution of hepatoceLlular Carcinoma in Post-transplant HCC Recurrence

HELP-2020
Start date: September 10, 2020
Phase:
Study type: Observational

Objective of Study: This study will evaluate the heterogeneity and evolution pathway between primary HCC and tumor relapse after liver transplant. According to the "Seed-Soil" theory, the primary hypothesis of this study is that HCC patients with different molecular-subtype experience altered different pattern of post-transplant recurrence, thus may have altered postoperative Recurrence-Free Survival (RFS). Because the donors' liver construct different microenvironment for CTC(circulating tumor cells) colonization. The investigators design this translational study to ①explore potential high recurrent risk HCC molecular-subtypes which might benefit from neoadjuvant systematic therapy or early adjuvant systematic therapy;②identify the molecular subtype heterogeneity of primary and recurrent HCC to guide the precision medicine.

NCT ID: NCT04504487 Completed - Liver Transplant Clinical Trials

Early Versus Routine Drain Removal After Live Liver Donor Hepatectomy

Start date: January 28, 2021
Phase: N/A
Study type: Interventional

It's a randomized control trial to compare early drain removal versus standard drain removal after donor hepatectomy in terms of donor outcomes. We will analyse the data and elucidate the safety of early drain removal using 3x3 rule with routine drain removal.

NCT ID: NCT04488094 Completed - Clinical trials for Liver Transplantation

Diagnostic Validity of [18F]FSPG PET for the Assessment of Acute Rejection After Heart or Liver Transplantation

Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

The a series of clinical studies of [18F]FSPG PET/CT showed that [18F]FSPG is safe and promising PET tracer for detecting inflammation with favorable biodistribution and pharmacokinetics in patients. By using [18F]FSPG, which targets system xCˉ, a key player in the active phase of inflammation, the goal of this phase 2 study is to evaluate diagnostic validity of [18F]FSPG PET/CT to detect allograft rejection after heart and liver allograft, where conventional imaging has limitations. Diagnostic efficacy of [18F]FSPG PET/CT will be determined in comparison with histologic evaluation of allograft biopsy. Other critical questions including whether quantitative measures of [18F]FSPG uptake is associated with the severity of rejection, inter-reader variability of [18F]FSPG PET/CT, and safety assessment will be also evaluated.

NCT ID: NCT04477967 Recruiting - Liver Diseases Clinical Trials

Design and Implementation of the Pediatric Liver Transplantation Biobank

Start date: October 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of the pediatric liver transplant biobank is to systematically collect clinical specimens from pediatric end-stage liver disease. It is expected to contribute to the research and development of paediatric end-stage liver disease in the future.

NCT ID: NCT04475887 Recruiting - Clinical trials for Liver Transplantation

Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation

TRAILER
Start date: July 23, 2020
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.

NCT ID: NCT04472312 Completed - Clinical trials for Liver Transplantation

Portal Pressure Effects of Phlebotomy Combined to Vasopressin Use in Cirrhotic Patients Undergoing Liver Transplantation

PORTAL
Start date: August 24, 2020
Phase:
Study type: Observational

Liver transplantation is the standard treatment for chronic advanced liver disease, whether or not associated with a primary liver tumor. The intraoperative bleeding and the need for blood transfusion, encountered in this major surgery are associated with increased morbidity and mortality. However, this hemorrhagic risk has been drastically reduced in the last 20 years and liver transplants without the use of blood products are now possible. Indeed, improvements in medical and surgical techniques associated with a better understanding of the pathophysiology of the cirrhotic patient have enabled this advance. One of the targeted therapeutic strategies is the control of portal hypertension. Several treatments have been sought, such as the use of splanchnic vasoconstrictors (such as vasopressin) and hypovolemic phlebotomy. These techniques reduce portal pressure and seem to reduce intraoperative bleeding with, even, a protective effect on kidney function. Their single-use or their combination is currently used in certain centers of expertise in liver transplantation. However, the hemodynamic effects of the combination of these 2 treatments on portal pressure has never been demonstrated. In this study, the effect of vasopressin, combined with a hypovolemic phlebotomy, on portal pressure in cirrhotic patients undergoing liver transplantation will be evaluated.

NCT ID: NCT04471441 Recruiting - Liver Transplant Clinical Trials

Efficacy and Safety of Everolimus Versus Mycophenolate Mofetil in Liver Transplant Recipients.

MONTBLANC
Start date: June 30, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of CertiroBell® tablet compared with mycophenolate mofetil in primary living donor liver transplant recipients.

NCT ID: NCT04462874 Completed - Liver Diseases Clinical Trials

Mean Systemic Filling Pressure Trends in Liver Transplant Recipients

Start date: July 15, 2020
Phase:
Study type: Observational

Patients with end stage liver disease undergoing liver transplantation have varying degrees of intraoperative haemodynamic unstability during various phases of transplantation. It is difficult to determine the cause for hemodynamic instability in these patients and to predict the best treatments. Currently, cardiovascular resuscitation options are triggered by arterial pressure and cardiac output (CO) measures, focusing on the oxygen delivery side of the circulation. The primary determinants of cardiac output reside on the venous side. Veins are 30-50 times more compliant than arteries and contain approximately 75% of the total blood volume. Mean systemic filling pressure provides vital information on this venous side of the circulation. Mean systemic filling pressure , which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. We would study the Mean systemic filling pressure in liver transplant recipients and record hemodynamic, respiratory, cardiac and renal function prospectively. Follow up data for 7 days for respiratory, cardiac and renal complications will be collected, along with hospital stay, ICU stay and mortality. The association between Mean systemic filling pressure and these outcomes will be analyzed.

NCT ID: NCT04446832 Recruiting - Cirrhosis Clinical Trials

VACcination of LIver Transplantation Candidates

VacLit
Start date: July 6, 2020
Phase:
Study type: Observational

Chronic hepatic disease, and especially cirrhosis, are associated to a global dysfunction of the immune system. Liver transplantation represents the only replacement therapy for end-stage liver disease and a curative means of localized hepatocellular carcinoma (HCC) but required immunosuppressive treatment to limit the risk of rejection. Candidates for liver transplantation are at an increased risk for severe infections, some of which can be prevented by vaccination. With regard to vaccine preventable diseases, these patients share the same pitfalls than all immunocompromised individuals: i) a theoretical or proven increased incidence and severity of certain infections warranting specific vaccine recommendations; ii) a decrease in immunogenicity of vaccine; iii) a risk of developing vaccine disease after administration of live attenuated vaccines. It is therefore recommended for all patients awaiting liver transplantation: i) updating the vaccinations recommended in general population (DTPw, MMR); ii) vaccination against viral hepatitis A and B to limit the risk of severe hepatitis; iii) vaccination against pneumococcal infection, influenza and chickenpox more common and more serious in this population. However, these recommendations are based on theoretical assessments and experts opinions; i) immunogenicity of vaccination in cirrhotic patients and persistence of post-transplant protection had been poorly assessed as well as their determinants; ii) there are only a few data regarding the tolerance of vaccinations in this population; iii) vaccination coverage of patients with end-stage liver disease is poorly known in France and; iv) the perception and acceptability of vaccinations have not been evaluated in this population. Investigators hypothesis is that: the vaccination schedule currently recommended for liver transplantation does not provide adequate protection against vaccine targets 6 months after liver transplantation.