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Liver Transplantation clinical trials

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NCT ID: NCT05818644 Enrolling by invitation - Pediatric ALL Clinical Trials

Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children

HEPATIC
Start date: September 28, 2023
Phase:
Study type: Observational

The goal of this observational study is to investigate the incidence, current management practices, and outcomes in pediatric patients with HAC after liver transplantation. Research question: - What are the overall incidence of HAC and the effectiveness of all treatment strategies for HAC after pediatric LT? - What are the current management practices in the experience of centers, anticoagulant therapy, screening protocol, and assessment criteria for HAC after pediatric LT? The burden of participation is considered to be minimal, and limited to the questionnaires.

NCT ID: NCT05655273 Enrolling by invitation - Clinical trials for Liver Transplant Rejection

Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients

Start date: January 1, 2024
Phase: Phase 4
Study type: Interventional

Prograf and Envarsus are two different formulations of Tacrolimus which is used as an immunosuppressant in liver transplant (LT) patients. Prograf is currently used as part of the standard immunosuppression regimen for LT recipients at UHN. This study will compare the use of Prograf and Envarsus and their effects on liver and renal function, trough tacrolimus levels, drug-related adverse effects, and patient adherence. Trial design is a pilot randomized trial. The study aims to recruit 40 patients from UHN's LT program and they will be randomized 1:1 to either stay on their current dose of Prograf or be converted to a once-daily equivalent dose of Envarsus. Both groups of patients will be followed for 48 weeks. This study will compare the change from baseline to week 48 in liver and renal function, tacrolimus-related side effects and patient reported outcomes between the two study groups.

NCT ID: NCT05224583 Enrolling by invitation - Clinical trials for Kidney Transplant Infection

Prevalence of BK Viremia in Simultaneous Liver-Kidney Transplant

Start date: November 17, 2021
Phase:
Study type: Observational

The human BK polyomavirus is a significant risk factor for renal transplant dysfunction and allograft loss. The prevalence of BK viremia (BKV) following kidney transplantation is estimated to be 10-20%.

NCT ID: NCT05195944 Enrolling by invitation - Diabetes Mellitus Clinical Trials

Semaglutide vs Sitagliptin

Start date: October 26, 2022
Phase: Phase 4
Study type: Interventional

The effect of once daily dosing of oral Semaglutide versus once daily dosing Sitagliptin on glycemic control, body weight, and safety and tolerability will be compared in Liver Transplant Recipients with poorly-controlled Diabetes Mellitus.

NCT ID: NCT05082077 Enrolling by invitation - Liver Diseases Clinical Trials

Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Start date: March 15, 2022
Phase:
Study type: Observational [Patient Registry]

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as retrospective standard of care patients

NCT ID: NCT05080595 Enrolling by invitation - Clinical trials for Liver Transplantation

Transportation Assistance Program for Liver Transplant

TAP-LT
Start date: January 24, 2022
Phase: N/A
Study type: Interventional

We propose a rideshare-supported intervention that leverages a partnership with Lyft Health, a HIPAA-secured logistics solution that enables us to provide reliable and efficient transportation for patients. Lyft rides will be provided to patients for any transplant-related medical visits, including but not limited to clinic visits with transplant providers, laboratory testing, and imaging/procedural testing that need to be performed as part of the routine evaluation process and prior to waitlisting for transplant.

NCT ID: NCT04804215 Enrolling by invitation - Clinical trials for Liver Transplant; Complications

Intraductal Transanastomotic Stent in Duct-to-duct Biliary Reconstruction in Liver Transplantation

Start date: November 25, 2022
Phase: N/A
Study type: Interventional

Liver transplant surgery has been used as a major treatment modality for end-stage liver disease, hepatocellular carcinoma and acute liver failure due to innovations in surgical treatment of donors and recipients over the past decade. However, despite these advances, biliary tract complications are considered the technical "Achilles tendon" of liver transplantation because of their high incidence, long-term interventions and potential risk of transplant failure. The incidence of biliary tract complications after liver transplantation is still a high incidence, with a prevalence of 10-50% despite increasing technology and experience worldwide. Biliary tract complications are typically biliary tract leakage and biliary stricture, which are the cause of post-transplant morbidity and transplant loss. Most of the bile leakage occurs within 3 months after surgery, and the incidence of these early complications reaches 10-20%. Biliary stricture is a late complication that usually occurs within 5-8 months and can occur up to 1 year. The incidence of biliary stricture currently reported is still occurring in 5-30% of large clinical studies. The use of external T-tubes to reduce biliary tract complications has been discussed for many years, and many published studies show no difference in biliary tract complications regardless of the use of T-tubes, as well as T-tube-related cholangitis and tube removal. Showed a relationship with certain morbidity rates, such as bile leakage. Insertion of a stent into the bile duct has the advantage of preventing biliary complications while avoiding the side effects associated with the use of external T-tubes. We presented a preliminary study of 100 patients and confirmed that intrabiliary stents reduced biliary tract complications, and not using an intrabiliary stent was an independent risk factor for biliary stenosis. Therefore, in this study, the purpose of this study was to determine the effective and rational use of intrabiliary stents through a randomized clinical trial according to the use of intrabiliary stents during biliary reconstruction in patients with liver transplant surgery. In addition, it is expected that clinical usefulness has not been announced until now in Korea, since a double-blind prospective randomized controlled clinical trial was conducted according to the presence or absence of an intrabiliary stent during biliary reconstruction in liver transplantation.

NCT ID: NCT04777032 Enrolling by invitation - Clinical trials for Liver Transplantation

The Danish Comorbidity in Liver Transplant Recipients Study

DACOLT
Start date: March 15, 2021
Phase:
Study type: Observational

Background: Liver transplantation is the only curative treatment for patients with end-stage liver disease. Short-term survival has improved due to improved surgical techniques and greater efficacy of immunosuppressive drugs. At present, the 10-year survival after liver transplantation is 60%, but long-term survival has not improved to the same extent the short-term survival. In addition to liver- and transplant-related causes, comorbidities such as cardiovascular, pulmonary, renal, and metabolic diseases have emerged as leading causes of morbidity and mortality in liver transplant recipients. The objective of this study is to assess the burden of comorbidities and identify both liver- and transplant-related risk factors as well as traditional risk factors that contribute to the pathogenesis of comorbidity in liver transplant recipients. Methods/design: The DACOLT study is an observational, longitudinal study. The investigators aim to include all adult liver transplant recipients in Denmark. Participants will be matched by sex and age to controls from the Copenhagen General Population Study (CGPS) and the Copenhagen City Heart Study (CCHS). Physical and biological measures including blood pressure, ancle-brachial index, spirometry, exhaled nitric oxide, electrocardiogram, transthoracic echocardiography, computed tomography (CT) angiography of the heart, unenhanced CT of chest and abdomen and blood samples will be collected using uniform protocols in participants in CGPS, CCHS and DACOLT. Blood samples will be collected and stored in a research biobank. Follow-up examinations at regular intervals up to 10 years of follow-up are planned. Discussion: There is no international consensus standard for optimal clinical care or monitoring of liver transplant recipients. The study will determine prevalence, incidence and risk factors for comorbidity in liver transplant recipients and may be used to provide evidence for guidelines on screening and long-term treatment and thereby contribute to improvement of the long-term survival.

NCT ID: NCT04592744 Enrolling by invitation - Acute Kidney Injury Clinical Trials

Angiotensin 2 for AKI After OLT

Start date: April 8, 2022
Phase: Phase 4
Study type: Interventional

Kidney injury is a common complication following liver transplantation and is associated with a higher complication rate and increased risk of death. While there are many factors that likely contribute to kidney injury in the perioperative period, a relative low serum level of angiotensin 2 (Ang 2) (a protein hormone that causes blood vessels to narrow) found in patients with liver cirrhosis (late stage of liver damage) may increase their risk of developing acute kidney injury (sudden episode of kidney failure or damage). We propose to investigate how early administration of Ang 2, a new vasopressor drug approved by the FDA in December 2017 for patients with low blood pressure, during the intra-operative period of liver transplant surgery affects the rate of kidney injury after transplantation. Patients who are deemed appropriate candidates for the study will be randomized 1:1 to the treatment and control groups. The intervention period of the study will occur in the operating room during transplant surgery and will be performed by their anesthesiologists. In the Treatment group, patients will receive Ang 2 infusions in addition to other standard vasopressors while patients in the control group will receive standard vasopressors alone. The infusion of Ang 2 in the treatment group will continue through the duration of the surgery and will be stopped prior to leaving the operating room. Both the treatment group and the control group will then be followed for 14 days to evaluate rates of kidney injury and to look for any complications. The follow up period will be extended to 28 days to look at in-hospital mortality rates in both groups. The daily follow up analysis will occur while the enrolled patients are inpatient following their transplantation surgery and will be done by looking at lab values and other data that is routinely gathered by their managing teams. This study will serve as a pilot study to evaluate feasibility of our protocol and to collect some preliminary data on the use of Ang 2 in this patient population. As such we plan to enroll approximately 30 patients who have accepted an offer to receive a donor liver. We hope to reach our goal enrollment within 5 months of starting the study.

NCT ID: NCT04348721 Enrolling by invitation - Clinical trials for Liver Transplantation

INTERNATIONAL SURVEY ON COMPLEXITY IN LIVER TRANSPLANTATION

Start date: April 1, 2020
Phase:
Study type: Observational

The aim of this study is to perform an online survey to assess the perception of international liver transplant surgeons regarding the complexity and surgical difficulty in liver transplantation and to develop a complexity score and classification.