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Liver Transplantation clinical trials

View clinical trials related to Liver Transplantation.

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NCT ID: NCT05895669 Recruiting - Death Clinical Trials

Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)

COLT
Start date: May 2, 2023
Phase:
Study type: Observational

All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.

NCT ID: NCT05890079 Completed - Postoperative Pain Clinical Trials

External Oblique Intercostal Plane Block for Liver Transplantation Donors

Start date: May 8, 2023
Phase: N/A
Study type: Interventional

Postoperative pain management is one of the important factors to improve rehabilitation and enhance recovery. External oblique intercostal plane block may be used for abdominal wall analgesia to provide effective analgesia for abdominal surgery. The aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block and subcostal transversus abdominis plane block in living liver donors. Researchers will compare the external oblique intercostal plane block group with subcostal transversus abdominis plane block to see if the external oblique intercostal plane block is effective for postoperative analgesia in living liver donors.

NCT ID: NCT05876052 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

HOPE to Reduce Tumour Recurrence After LT In Patients With HCC

POTERE
Start date: May 2023
Phase: N/A
Study type: Interventional

Hypothermic oxygenated ex-situ machine perfusion (HOPE) is a dynamic preservation method that has been developed to reduce the incidence and severity of ischaemia-reperfusion injury and to improve outcomes after liver transplantation. Whit this study Pi and collaborators hypothesize that the application of ex-situ liver perfusion before LT in HCC recipients leads to an optimization of graft function, with a decrease in ischaemia-reperfusion injury and a possible decrease in tumor cell growth. This is multicentre, prospective, two-arm, randomized, controlled, clinical trial, that will will involve patients with HCC candidate to LT. The liver grafts will be randomized in two groups to compare HOPE and static cold storage (SCS) preservation before transplantation. For each group evaluation of clinical outcomes, graft function tests, histologic findings, perfusate, tumor characteristics, and recurrence will be done.

NCT ID: NCT05866796 Recruiting - Clinical trials for Liver Transplant Failure

Serum GLYcomics to Predict Graft Loss and Mortality After Liver Transplantation

GLYGALT
Start date: April 26, 2023
Phase:
Study type: Observational

The first 12 months after liver transplantation (LT) are decisive in posttransplant outcome, as almost half of deaths and two thirds of graft loss requiring retransplant occur in the first year after LT. Since delaying retransplantation in those patients that experience an unfavorable posttransplant course directly impacts their outcome, timely decision making is of paramount importance in these individuals. However, balancing the need and right timing for retransplantation in individual patients with a complicated posttransplant course is currently a difficult challenge that relies on imperfect clinical variables and biomarkers, as well as the experienced judgment of the transplant team. Building on the findings of a pilot study in liver transplant recipients (n = 131) led by the Ghent University Hospital, we want to validate the prognostic performance of the GlycoTransplantTest on a multicentric scale. In this pilot study, a single glycomic signature at day 7 after LT allowed accurate prediction of graft loss at 3 months after LT. The serum glycome of those patients experiencing graft loss was characterized by increased undergalactosylation and an increased presence of fucosylated and triantennary glycans. After statistical modeling, use of an optimized cutoff based on the relative abundance of 13 serum glycans showed a strong association with graft loss at 3 months (odds ratio 70.211; P<0.001; 95% CI: 10.876-453.23). Using sequential measurements of serum glycomics in liver transplant recipients, we want to prospectively study and validate the predictive value of the serum glycomic signature for graft survival and overall survival at 3-months (primary end point) and 12-months after liver transplantation (secondary end point). Determination of the serum glycomic profile is a high-throughput technique that allows to study and quantify the relative abundance of sugar chains (glycans) anchored at specific sites of serum proteins. This technique has shown a very strong prognostic value for graft loss at 3-months after liver transplantation in a pilot study at the Ghent University Hospital. In this large-scale multicentric prognostic study, we will collect serum samples of liver transplant recipients at fixed time points. Apart from the serum glycomic profile, we will collect data from the patients electronic record: demographic data (gender, age), data directly relevant to the indication of transplant (eg. imaging for primary liver cancer, lab values for diagnosis of end-stage liver disease), and outcome data (graft survival, overall survival, follow-up time). This list is non-exhaustive. Using this approach, we will demonstrate the predictive validity of serum glycomics in liver transplant recipients for graft survival and overall survival at 3- and 12-months post-LT. Building on these data, the use of a simple blood test could differentiate patients at risk of graft loss and thus represent a paradigm shift directing these patients to timely treatment adaptations.

NCT ID: NCT05866783 Recruiting - Clinical trials for Hepatocellular Carcinoma

Serum Glycomics as Prognostic and Diagnostic Biomarkers of Disease Recurrence in Liver Transplant Recipients With Hepatocellular Carcinoma

GLITCA
Start date: April 28, 2023
Phase:
Study type: Observational [Patient Registry]

Liver transplantation (LT) is the only curative option for a selection of patients with hepatocellular carcinoma (HCC) based on clinical selection criteria known as the Milan criteria. Nevertheless, 15% of these patients still show tumour recurrence after LT. In a monocentric pilot study, we have demonstrated that specific changes in N-glycan profiles (measured before LT) occur in HCC patients receiving LT1. These specific changes proved to be strongly associated with the risk of HCC recurrence and overall death after LT, independent of the criteria used for stringent patient selection. Pathophysiologically, it is known that abberations in protein glycosylation are involved in the onset en development of HCC. As such, a prognostic biomarker was developed that can clearly differentiate between patients with and without increased risk of HCC recurrence. The primary goal of this research study is to set up a prospective, multicentre study in order to validate the prognostic value of this glycomics-based serum biomarker. As such, the risk of tumour recurrence in patients undergoing LT for HCC will be estimated independent from the Milan criteria and the French alpha-fetoprotein model as the current standard. The secondary goal is to explore the potential of serum glycomics as markers of early recurrence after LT for HCC. More specifically, we aim to investigate whether serial glycomics determination at fixed time points after LT could allow early detection of recurrent HCC even before it is visible on conventional imaging. Consequently, a diagnostic biomarker for monitoring early recurrence after LT could be developed with the potential of redirecting treatment strategies already in an early disease stage. In case the promising data from the pilot study will be confirmed, the prognostic biomarker could be implemented in daily clinical practice leading to optimization of patient selection using a simple blood test before LT. More specifically, this marker could improve organ allocation thus preventing unnessecary treatment toxicity for the patient and reducing the costs of treatment for society. Moreover, it should be emphasized that a patent application was already submitted and accepted in collaboration with TechTranfer of Ghent University (PCT/EP2021/057788-Prognostic markers of disease recurrence in liver transplant recipients with hepatocellular carcinoma).

NCT ID: NCT05854472 Recruiting - Clinical trials for Liver Transplantation

Using Smartphone Application After Liver Transplantation

Start date: February 27, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized controlled clinical study was a study that could facilitate the management of immunosuppressive therapy, including information specific to liver transplant patients, to increase immunosuppressive medication adherence and quality of life, and reduce anxiety in the early period in patients who have to use lifelong immunosuppressive medication to prevent organ rejection after liver transplantation. The aim of this study is to develop a smartphone application and evaluate the effectiveness of the application. Research Question: What is the effect of smartphone application use on immunosuppressive medication adherence, anxiety and quality of life in patients undergoing liver transplant? Research Hypotheses H11: There is a difference between medication adherence in patients who use and do not use smartphone applications after liver transplantation at the 3rd month after discharge. H21: There is a difference between the anxiety levels of the patients who used and did not use smart phone applications after liver transplantation in the first month after discharge. H31: There is a difference between the anxiety levels of the patients using and not using smart phone applications after liver transplantation at the 3rd month after discharge. H41: There is a difference between the quality of life of patients using and not using a smart phone application after liver transplantation, at the first month after discharge. H51: There is a difference between the quality of life of patients who use and do not use smart phone applications after liver transplantation at the 3rd month after discharge. H61: There is a difference between immunosuppressive blood drug levels in the 1st month after discharge in patients who use and do not use smart phone applications after liver transplantation. H71: There is a difference between the immunosuppressive blood drug levels in the 3rd month after the discharge of the patients who used and did not use the smart phone application after liver transplantation. H81: There is a difference between the rejection rates of patients who use and do not use smartphone applications after liver transplantation, within the 3 months after hospital discharge. H91: There is a difference between the rates of readmission within the 3 months after hospital discharge in patients who use and do not use smart phone applications after liver transplantation. Researchers will compare the experimental and control groups to see if there is a difference between patients' adherence to medication, quality of life, and anxiety levels. The experimental group is going to use the smartphone application developed specifically for patients with liver transplantation for 3 months.

NCT ID: NCT05853484 Not yet recruiting - Liver Cirrhosis Clinical Trials

Home-based Bimodal Lifestyle Intervention in Patients With Liver Cirrhosis Awaiting Orthotopic Liver Transplantation

FIT4Cirrhotics
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Chronic liver disease eventually results in liver cirrhosis and is associated with an increasing deterioration in patients' physical fitness. As there is currently limited evidence regarding the effects of a home-based exercise program in patients with liver cirrhosis awaiting OLT, and physical frailty rates are particularly high in this patient population, this group has the investigators specific interest. The primary aim of this study is to assess the effect of a semi-supervised home-based bimodal lifestyle program, consisting of interval and endurance training and peripheral resistance training on aerobic capacity in patients with liver cirrhosis awaiting OLT

NCT ID: NCT05852964 Active, not recruiting - Infections Clinical Trials

Inflammatory and Anti-Inflammatory Gene Expressions in Liver Transplant Patients

Start date: May 3, 2023
Phase:
Study type: Observational

In our study, some inflammatory Interleukin-2 , Interleukin-6, Interferon-γ, Tumor Necrosis Factor-α and anti-inflammatory Interleukin-4 and Interleukin-10 cytokine genes expressions and Triggering Receptor Expressed On Myeloid Cells- 1, which contributes to the pathology of acute and chronic inflammatory diseases; Human Leukocyte Antigen-G5, which suppresses the immune response; the expression levels of transcription factor Forkhead box-P3 expressed in regulatory T-lymphocytes and Cluster of Differentiation (CD)14 genes, which are thought to be biomarkers in various infectious diseases and expressed in monocytes, will be measured from peripheral blood samples obtained from liver transplant patients before, 1 month and 6 months after the operation. In addition, the classical liver markers Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Platelet Count (PLT), Alpha Feto Protein (AFP), Direct Bilirubin (Bilirubin D), Total Bilirubin (Bilirubin T) and C- Levels of biochemical parameters such as Reactive Protein (CRP) will be measured. In the light of the data to be obtained, it is aimed to find biomarkers with high predictive value for rejection and infection after liver transplantation.

NCT ID: NCT05835882 Recruiting - Clinical trials for Liver Transplantation

Blood Salvage From Liver Donors: a Feasibility Pilot Study

BLEED
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Blood recovery is a common procedure that limits patient exposure to allogeneic blood products. Blood recovery is usually performed during different types of surgery, including cardiac and vascular surgery, or liver transplantation. Basically, the process utilizes blood cell savers and cell separators and is finalized to auto-transfusion. In our hospital, the blood recovery is carried out with the CATSmart continuous-flow device (Fresenius Kabi AG, Bad Homburg, Germany) that warrants the removal of > 95% of heparin, potassium, free hemoglobin, and non-emulsifiable lipids. In liver transplantation (LT), before removing the organ from the donor, the blood is usually flushed out of the liver. Nonetheless, in some circumstances, donor blood cells may be transferred to recipients together with the solid organ during graft implantation. This is a feasibility study exploring RBC (red blood cell) concentrates obtained from the blood organ donor to support transfusion requirements in liver recipients. Donor RBC units are produced according to the quality standards recommended by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe, with equivalent content of Hb and residual leukocytes as standard RBC products.

NCT ID: NCT05822570 Recruiting - Clinical trials for Liver Transplantation

Oxygen Dissociation Curve in Patients Undergoing Orthotopic Liver Transplantation

Start date: May 1, 2023
Phase:
Study type: Observational

Hemoglobin (Hb) is the molecule responsible for the transport of oxygen (O2) to the tissues in mammals. The p50 and the Hill coefficient (HC) best describe the ODC. The interaction between Hb and O2 can be influenced by many agents and conditions like temperature, pH, pCO2 and 2,3-diphosphoglycerate (2,3-DPG). During liver transplantation numerous profound physiological changes occur, linked to the different stages of the surgical procedure. Previous studies in humans and animals undergoing liver transplantation have shown that while the ODC seems preserved during preparation and the anhepatic phase, a left shift of the ODC occurs after reperfusion . This left shift of the ODC could imply a decreased release of oxygen to the tissues, probably worsening hemodynamic instability. With this pilot study the investigator aim to measure ODCs at baseline and at different stages during orthotopic liver transplantation in patients in order to get deeper understanding of oxygen delivery and supply during liver transplantation surgery.