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Liver Transplantation clinical trials

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NCT ID: NCT03456284 Active, not recruiting - Clinical trials for Liver Transplantation

Safety and Feasibility of Normothermic Machine Perfusion to Preserve and Evaluate Orphan Livers

Start date: March 12, 2020
Phase: N/A
Study type: Interventional

Orphan livers are organs that have been declined for clinical use by all centers due to their marginality. The current standard of care of liver preservation before transplant is cold storage. NMP may allow these livers to be evaluated before transplantation. NMP has already been used in a clinical setting with promising results. The advantage to utilizing NMP is that it would attenuate the incidence and clinical impact of classical preservation injury, allow liver function assessment before implantation and thus improve donor pool and outcomes for high risk ECD liver transplants performed at our center.

NCT ID: NCT03396016 Active, not recruiting - Clinical trials for Liver Transplant Failure

Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation

Start date: April 18, 2018
Phase:
Study type: Observational

Factor V is a coagulation cofactor that is primarily produced by the liver. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may be a reliable biomarker for hepatic function after LT. Therefore, the aim of this study is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Patients undergoing LT at the University Health Network will have plasmatic Factor V levels measured during postoperative week 1. Patients will be followed up to 12 months. The study outcomes will be early graft dysfunction, and graft and patient survival. Graft loss will be defined as need for retransplantation in the study period.

NCT ID: NCT02556879 Active, not recruiting - Clinical trials for Liver Transplantation

Immunization Anti HLA in the Liver Transplant Recipients (DSATH)

DSATH
Start date: March 9, 2016
Phase: N/A
Study type: Interventional

Anti HLA alloimmunization against the donor evaluated by the detection of anti-donor specific antibodies (DSA) is an underestimated factor in liver transplantation and may contribute to dysfunction and graft loss , especially among candidates for retransplantation, that have major immunization. This study will analyzed immunization markers at the time of liver retransplantation and systematically in patients follow-up. This will allow to characterize the histological lesions due to humoral immunization, to establish further investigations and to adapt early immunosuppressive therapy.

NCT ID: NCT01960868 Active, not recruiting - Clinical trials for Liver Transplanted Patients

Early Rehabilitation Program is Feasible and Safe in ICU in Liver Transplanted Patients

Start date: October 2013
Phase: N/A
Study type: Interventional

Liver transplantation is the last surgical treatment for patients with acute or chronic liver disease. Transplantation therapies technics are in constant evolution. It allows an increasing survivals rates and time to come back to daily activities. The postoperative treatment after abdominal surgery as Liver Transplantation (LT) is usually performed in Intensive Care Unit (ICU).This postoperative phase is one of the most important steps regarding the involvement of the rehabilitation of the patient (Rongies 2005). Physical abilities transplantation are likely to be important in the postoperative. It appears that pre-transplant subjects have a weakened muscle potential, they will increase it significantly in the months after transplantation with a rehabilitation program adapted (Beyer 1999). Length of stay in ICU depends on surgery complications. Inactivity induced by sedation and ICU length of stay are major factor for increasing complications as respiratory disorders and muscle weakness. Several studies have reported feasibility and safety an early mobility program in ICU, especially regarding the length of stay decrease (Bailey 2007; Morris 2008; Schweickret 2009, Needham 2010; Bourdin 2010) These early mobility programs encompass muscle strength assessment, passive range of motion, active mobility, sitting on the edge of bed, standing and walking, which would be related to the primary disease of LT (Rongies 2008). The assessment of the strength for ICU patient is feasible and reproducible with the Medical Research Council score (MRC score). The MRC score consists in an assessment of three muscle groups of upper and lower limbs. Sitting positions and verticalization are included in programs begun as soon as possible after surgery evaluation of the response level to verbal stimulation and physical abilities (Gosselink 2011). The skills of the physiotherapist are established in legal texts making him a key in the assessment and management of these patients on musculoskeletal and respiratory domains. The purpose of this study is to validate data feasibility and tolerance. Another aim is also to assess the length of stay in ICU, of early mobility and physical program, started in the postoperative period in a population of patients with liver transplantation, during their stay in ICU of Prof. Albanese. Thus, we decided to carry out a parallel study, open, randomized monocentric comparing two groups of patient liver transplanted. The control group will receive the standard treatment used in the ICU and the experimental group will receive a protocol of early mobilization according to data from recent literature on the subject. The study is scheduled to last over one year and included patients will receive physical therapy on five days a week with a frequency of one to several times per day depending on the clinical requirements or conditions of the study.

NCT ID: NCT01944527 Active, not recruiting - Clinical trials for Liver Transplantation

Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection

ANRSCO23CUPILT
Start date: October 2013
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence. This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.

NCT ID: NCT01836718 Active, not recruiting - Clinical trials for Liver Transplantation

Assessment of Intrahepatic Hepatitis C Virus (HCV) RNA Levels at the Time of Liver Transplantation

Start date: June 2013
Phase: N/A
Study type: Observational

The purpose of this study is to measure intrahepatic HCV RNA levels at the time of liver transplantation in patients receiving antiviral therapy while on the liver transplant waiting list. This will eventually be correlated with the degree of hepatic fibrosis present within different geographic sites in the cirrhotic liver. Tissue samples will be obtained from the patient's liver explant as well as hilar lymph nodes. Upon the removal of the cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times in different segments of the liver and preserved for viral detection studies as well as analysis of the degree of fibrosis. Peripheral blood mononuclear cells (PBMCs) will be obtained for viral detection at the time of transplantation. Serum HCV RNA levels will also be obtained at 1 month, 3 months and 6 months post liver transplantation. Study Hypotheses: - Virological relapse or non-response is higher is patients with cirrhosis due to failure of antiviral medication to concentrate adequately in a fibrotic liver having an altered sinusoidal micro-architecture - HCV may persist in different geographic regions of the fibrotic liver in part predicated on blood supply to that area and this may have an effect on overall virological response. These differences in viral persistence and detection may exist in different lobes of the liver or even within a few centimeters within the same portion of the liver parenchyma. - PBMC and hilar lymph nodes may be extrahepatic reservoirs of HCV viral persistence in patients receiving antiviral therapy and may account for virological relapse post-therapy - There may be varying degrees of fibrosis within the same cirrhotic liver which may impact on hepatic synthetic function and antiviral response to treatment.

NCT ID: NCT01525797 Active, not recruiting - Clinical trials for Liver Transplant Recipients

Blood Draw Study for Liver Transplant Patients

Start date: October 2002
Phase: N/A
Study type: Observational

The purpose of this study is to see what a lab test will show and if there is a way to predict which patients will be more likely to have rejection after receiving a liver transplant.

NCT ID: NCT01294020 Active, not recruiting - Clinical trials for Kidney Transplantation

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®

Start date: May 25, 2011
Phase: Phase 2
Study type: Interventional

Parts A & B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy. Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.

NCT ID: NCT01172691 Active, not recruiting - Liver Transplant Clinical Trials

Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

Start date: July 2010
Phase: Phase 2
Study type: Interventional

This study is being done to determine if patients receiving (iNO) will have increased liver function and less damage from IR than patients who do not receive (iNO).

NCT ID: NCT00647283 Active, not recruiting - Clinical trials for Liver Transplantation

Assessment Of the Safety and Benefit of Prospective Immunosuppressive Drug Withdrawal in Liver Transplantation and Prediction of Operational Tolerance

Start date: November 2005
Phase: Phase 2
Study type: Interventional

In liver transplantation up to 20% of recipients can completely discontinue immunosuppressive therapy maintaining normal graft function, and are conventionally considered as operationally tolerant. Discontinuation of immunosuppressive drugs in operationally tolerant recipients could lessen the side effects of chronic immunosuppressive therapy. However, this strategy results in the development of rejection in a high proportion of recipients who require lifelong immunosuppression. Thus, there is a need to identify predictive factors of successful drug withdrawal and to define the clinical and histological outcomes of operationally tolerant liver recipients. The main objective of this study is to establish the safety of attempting immunosuppressive (IS) drug withdrawal in stable liver transplant recipients, using standard clinical, biological and histopathological methods, to screen and follow-up patients, and to confirm the benefit of maintaining immunosuppressive drug interruption in patients who are tolerant to their liver transplant. The secondary objective of this study is to identify predictive factors of operational tolerance and to attempt to develop a multi-parameter "decision rule" to predict patient tolerance or non-tolerance in order to improve patient screening and follow-up. In a diagnostic observational sub-study, peripheral blood and liver tissue samples collected before immunosuppressive drug withdrawal will be employed to validate the diagnostic accuracy of a previously identified set of tolerance biomarkers and to identify potential new biomarkers capable of predicting the outcome of the immunosuppressive withdrawal protocol.