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Liver Transplantation clinical trials

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NCT ID: NCT05153915 Completed - Clinical trials for Kidney Transplantation

A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

Start date: December 30, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen.

NCT ID: NCT05152628 Completed - Clinical trials for Kidney Transplantation

A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

Start date: January 11, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or kidney transplantation. This study will also observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.

NCT ID: NCT05132192 Completed - Clinical trials for Liver Transplant; Complications

Living Donor Liver Transplantation to Patients With Portal Vein Thrombosis

Start date: January 1, 2013
Phase:
Study type: Observational

Data of demographic, clinical, laboratory and imaging studies of living donor liver transplantation (LDLT) recipients from two transplant centers were collected. Survival and morbidity rates between patients with and without portal vein thrombosis (PVT) were compared. Risk factors of mortality in the setting of PVT were identified. Intraoperative portal flow measurements were compared before and after portal flow restoration.

NCT ID: NCT05116748 Completed - COVID-19 Clinical Trials

COVID19 Vaccine in SOT Adult Recipients

COVID19_VaxSOT
Start date: October 1, 2021
Phase:
Study type: Observational

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only. Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19 Visits and timepoints: - T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status - Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination - T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity - Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

NCT ID: NCT05108636 Completed - Sleep Clinical Trials

The Effect Of Therapeutic Touch and Music Rest on Sleeping Applied to Children With Liver Transplantation

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Today, the demand for liver transplantation is increasing day by day, since liver transplantation is considered the most effective treatment for end-stage liver disease. Patients who have undergone major surgery such as liver transplantation may experience sleep-related problems due to common complications of surgical procedures. However, in some studies, it is stated that practices such as acupuncture, exercise, mindfulness, therapeutic touch, listening to music, yoga, etc., performed by nurses, reduce the sleep-related problems of patients. In this study, the effects of therapeutic touch and music on the sleep of children with liver transplantation will be examined.

NCT ID: NCT05096754 Completed - Liver Transplant Clinical Trials

OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study

Start date: February 3, 2020
Phase:
Study type: Observational

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.

NCT ID: NCT05096741 Completed - Liver Transplant Clinical Trials

OCS Liver PROTECT Continuation Post-Approval Study

Start date: January 24, 2016
Phase:
Study type: Observational

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT Trial.

NCT ID: NCT05087550 Completed - Liver Transplant Clinical Trials

Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation

Start date: October 13, 2021
Phase:
Study type: Observational [Patient Registry]

Organ procurement organizations (OPO) have increased organ recovery efficiency and yield and have also reduced organ acquisition charges. The new liver allocation policy came into effect in February 2020 and aims to increase access to organs for waitlist candidates with the greatest severity of illness. The urgent change was driven by the perception that patients were dying because of arbitrary boundaries and inequitable access. Critics of the new policy have highlighted the potential cost implications particularly at an OPO level. A study of five OPOs throughout the United States highlighted an increase in costs ranging from 43% - 206% despite the same volume of livers transplanted. The main reason for the cost appears to lie in organ handling and transport. This mirrors the findings of Puri and colleagues who acknowledged changes to lung transplantation at Barnes Jewish Hospital in the pre- and post-policy eras and reported a substantial decline in local donors. The new lung system has also resulted in a higher organ discard rate and ultimately higher costs. Such data has generated meaningful discussions regarding optimizing organ allocation polices, however, data from individual transplant centers is lacking in the literature. Changes at a transplant center level relating to recipient costs are likely impacted by the new policy, which could be related to patient travel, accommodation, work up etc.

NCT ID: NCT05068713 Completed - Clinical trials for Liver Transplant; Complications

High Versus Low Blood-Pressure Target in the Post Operative Care of Liver Transplantation A Randomized, Controled, Open and Unicentric Trial.

LIVER-PAM
Start date: August 24, 2021
Phase: Phase 3
Study type: Interventional

LIVER PAM A randomized, controled, open and unicentric trial comparing high (MAP 85-90 mmHg) and low (65-70 mmHg) target of mean arterial pressure in the first 24 hours after liver transplantation.

NCT ID: NCT05037838 Completed - Clinical trials for Liver Transplant; Complications

Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation

STRAIN ETO
Start date: November 1, 2020
Phase:
Study type: Observational [Patient Registry]

Mycocardial systolic function (contractility) is an essential element of cardio-circulatory physiology during major visceral surgery, in particular during liver transplantation during which several factors are likely to be at the origin of a ventricular dysfunction: acute hemorrhage, major volume changes, acute pulmonary arterial hypertension and ischemia-reperfusion syndrome. Ventricular dysfunction is an underestimated intraoperative liver transplantation phenomenon while it constitutes a risk factor for peroperative and postoperative morbidity and mortality established that graft function can be compromised through the phenomena of low cardiac output and hepatic congestion. Also, better analyzing myocardial systolic function during liver transplantation could guide practitioners in the treatments to be undertaken, evaluate their effects and diagnose various complications. In addition, the usual cardiac output measurement systems (transpulmonary thermodilution techniques and pulse wave contour analysis) are poorly suited to liver transplantation. Frequent variations in blood volume, vasomotor tone and temperature require regular recalibrations and prevent a continuous and reliable estimate of cardiac output. Thus, the choice of hemodynamic monitoring during liver transplantation performed in our center is transesophageal ultrasound, a semi-invasive method with a favorable benefit-risk ratio in this category of the population. However, analysis of right ventricular systolic function by classical indices is difficult in transesophageal ultrasound for reasons of alignment of the ultrasound shot on the right ventricular. The analysis of left ventricular systolic function is complex due to the sudden variations in volume and the difficulty in carrying out planimetry measurements in real time. Myocardial strain imaging has been developed in recent years and is widely validated for the assessment of left ventricular contractile function. It was subsequently applied to the exploration of the right ventricular. Its measurement can be performed from recordings on dedicated software. Thus, the strain could make it possible to better assess myocardial systolic dysfunction in liver per-transplantation from the transesophageal echographic loops recorded in current practice at the different operating times. Strain measurements will be carried out a posteriori from the images which are acquired in a standard way during the operation.