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Liver Failure clinical trials

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NCT ID: NCT03668171 Recruiting - Clinical trials for Acute-On-Chronic Liver Failure

Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure

Start date: December 10, 2017
Phase: N/A
Study type: Interventional

Mesenchymal stem cells (MSC) has been reported to improved outcomes of acute-on-chronic liver failure(ACLF). More randomization controlled studies are needed to confirm the effect of MSC treatment for ACLF. This study aimed to investigate the efficacy of mesenchymal stem cells in ACLF patients. This study is an double-blind multicenter randomized and placebo-controlled study. Patients with with ACLF will be randomly assigned to receive MSC treatment (experimental) or standard medical treatment (control). Three times of MSC infusion (0.1-1x10E6cells/kg body weight) via peripheral vein will be given to the experimental group (once per week). The primary outcome is 12 week mortality. Secondary outcomes are clinical remission rate and changes of liver function indices and liver function scores.

NCT ID: NCT03640728 Recruiting - Hepatitis B Clinical Trials

The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure

Start date: January 25, 2019
Phase:
Study type: Observational

HBV-related acute-on-chronic liver failure (ACLF) is a clinical syndrome defined as acute hepatic insult with diagnosed or undiagnosed chronic liver disease. Current clinical guidelines advocate oral antiviral treatment in HBV-related ACLF. However, no conclusion on which nucleoside analogue is the most satisfactory drug for the treatment of HBV-related liver failure has not been reached yet. In this cohort study, the investigators will compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF), Tenofovir Disoproxil Fumarate (TDF) and entecavir (ETV) in HBV-related ACLF in China. In addition, the drug metabolism characteristics of TAF will be explored in such severe liver injury population of HBV-ACLF.

NCT ID: NCT03627013 Recruiting - Kidney Failure Clinical Trials

Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)

Start date: May 23, 2019
Phase: Phase 3
Study type: Interventional

Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol number: CL-N-KLP-TX-III/07-AT/17 Trial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver. Intended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days). Purpose of the study The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas. Patient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study. Planned number of patients (recipients) In total N=362 including: Kidney 242 (including approx. 30 combined kidney-pancreas) Liver 120

NCT ID: NCT03598465 Recruiting - Clinical trials for Post-hepatectomy Liver Failure

Evaluating the Association Between Sphingolipid Metabolites and Post-hepatectomy Liver Failure

Start date: March 5, 2019
Phase:
Study type: Observational

Hepatectomy is an essential treatment for various benign and malignant diseases of the liver. However, post-hepatectomy liver failure (PHLF) is still a life-threatening complication after hepatectomy. The pathophysiological mechanism of PHLF has not yet been fully elucidated, and there is still a lack of effective strategies for either prevention or therapy of PHLF. Sphingolipids include ceramides (CER), sphingomyelins (SM), glycosphingolipids (GSL), sphingosine (SPH), and sphingosine-1-phosphate (S1P) are multi-functional lipids that regulates cell proliferation, cell survival, cell death, inflammation, tissue fibrosis, cancer cell metastasis, and invasion. Liver is a main organ for metabolizing sphingolipids, dysregulation of specific sphingolipids is associated with several liver diseases, therefore sphingolipids have been proposed to be biomarkers of liver diseases, including hepatitis, liver cancer, fatty liver diseases, and liver fibrosis. Moreover, several studies have shown CER, SPH and S1P are critical in regulating pathophysiology of liver diseases, including liver regeneration, necrosis, and inflammation. Given that PHLF causes dramatic dysregulation in biochemical metabolism in liver, the investigators hypothesize that dysregulation of sphingolipid metabolism may also occur in PHLF, and the dysregulation of specific sphingolipids may serve as a biomarker or regulator during progression and recovery of PHLF. This project will examine the association between sphingolipid metabolism and PHLF. Levels of sphingolipid metabolites and their related enzymes in plasma and liver tissue of patients with hepatic resection will be measured by using liquid chromatograph/electrospray ionization/mass spectrometry (LC-ESI-MS/MS) and high-throughput real-time quantitative PCR. This project will facilitate us to identify specific sphingolipid metabolites as biomarker and regulator of PHLF.

NCT ID: NCT03509194 Recruiting - Liver Cirrhosis Clinical Trials

Better Diagnostic Tools for Children and Adolescents With Acute Liver Failure and Chronic Liver Insufficiency

DAKL
Start date: December 17, 2017
Phase:
Study type: Observational

The aim of this study is to validate and develop a new diagnostic and prognostic approach for assessment of liver function in children and adolescents with acute liver failure and chronic liver insufficiency. A carefully selected panel of functional and genomic tests along with diagnostic imaging and analysis of the microbiota will be performed in children and adolescents with acute liver failure and chronic liver insufficiency at Rigshospitalet. The tests will be performed in a serial manner in order to detect changes in outcomes. The study is an unblinded descriptive study, and approximately 20 patients with acute liver failure and 100 patients with chronic liver disease will be included in the project. This study will be the first of it's kind worldwide. The investigators expect the study to improve future diagnostic and prognostic accuracy and help the clinicians in identifying those patients in which the liver will regenerate itself, from those patients in which a liver transplantation will be lifesaving. Furthermore this study aims to help the clinicians in defining the optimal time for pediatric liver transplant in a narrow window of opportunity.

NCT ID: NCT03281252 Recruiting - Hemostatic Disorder Clinical Trials

A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China

Start date: April 16, 2017
Phase: N/A
Study type: Observational

Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. However, the minor and major bleeding events has not been described yet. We observe the patients' major and minor bleeding events and use 4 criteria, which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in ACLF patients and pre-ACLF patients.

NCT ID: NCT03216668 Recruiting - Clinical trials for Liver Function Failure

TONKA Versus Legalon for Lowering Hepatic Enzymes in Liver Function Disorder Patients.

Start date: June 15, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after 6 weeks of treatment.

NCT ID: NCT03000621 Recruiting - Liver Failure Clinical Trials

Comparative Study of Circulating microRNA Changes in Patients With Liver Injury and Healthy Subjects

Start date: December 2016
Phase: N/A
Study type: Observational

The objectives are to: 1. validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without liver injuries 2. investigate the physiological range of the circulating miRNA panel in Healthy Subjects and under stress 3. investigate the dysregulation of circulating miRNA panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and acute liver failure. This trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. The investigators will develop panels of miRNAs that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these miRNAs.

NCT ID: NCT02882347 Recruiting - Liver Failure Clinical Trials

The Effect of Somatostatin for Treatment of Post Hepatectomy Liver Failure (PHLF)

Start date: July 2015
Phase: Phase 3
Study type: Interventional

Post hepatectomy liver failure (PHLF) is a serious medical problem could lead to patient death, however, definite treatment strategy has not been established. The liver is a regenerating organ and the possibility of PHLF could be reduced when the appropriate liver regeneration is guaranteed. Portal flow has known to be important during liver regeneration. Low portal flow cannot induce proper regeneration, contrary, excessive flow increase shear stress in the hepatic sinusoid resulting liver failure. Various medications has been used in malignant liver cirrhosis to reduce portal pressure. Among them, somatostatin has been used modulating portal flow reducing portal and sinusoidal pressure. In this study, the investigators administrate somatostatin at a rate of 3.5ug/kg/hour to PHLF patients (prothrombin time < 50% and serum total bilirubin > 2.9mg/dl after liver resection) until recovery from liver failure. For assessment of the recovery of liver failure, the investigators evaluate aspartate transaminase (AST), alanine transaminase (ALT), serum total bilirubin and prothrombin time periodically after administration of medication.

NCT ID: NCT02757170 Recruiting - Cirrhosis Clinical Trials

Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography

Start date: July 2015
Phase: Phase 4
Study type: Interventional

Patients of acute & chronic liver failure have long been assumed to have coagulopathy & are given blood products prophylactically as well as during various interventions. But these patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation parameters are insufficient to assess coagulation status of these patients because they reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives a comprehensive report of hemostatic profile including platelet function. Studies using TEG have suggested that defects in prohemostatic drivers are counterbalanced by changes in antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a entity with acute decompensation on underlying chronic liver failure. Since there is paucity of data regarding coagulation abnormalities in these patient, study is needed to assess predictability power of TEG in these patients with respect to coagulation abnormalities in patient with ALF and CLD ( cirrhosis) and healthy controls.