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About
The purpose of this study is to establish the safety of the combined drug approach (anti-thrombin III, infliximab, apotransferrin, human recombinant erythropoietin beta, C1-inhibitor, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce ischemia-reperfusion injury during liver transplantation in eligible recipients.
Enrollment
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Volunteers
Inclusion criteria
Patients suffering from irreversible liver failure eligible for liver transplantation according to Eurotransplant guidelines. Patients > 18 years of age at time of listing on Eurotransplant waiting list for liver transplantation in University Hospitals Leuven, Belgium.
Exclusion criteria
Patients who refuse to participate in the study. History of hypersensitivity to one/several component(s) of the combined drug approach.
Conditions that prevent the use of the combined drug approach:
Administration of heparin at therapeutic dose pre-operatively, Congestive heart failure, Pre-operative level of hemoglobin higher than 13 mg/dl, History of seizure, poorly controlled arterial hypertension, myocardial infarction or stroke in the month preceding the liver transplantation, venous thromboembolic disease, Unstable angina pectoris, Sepsis, abcesses or opportunistic infections, History of infliximab treatment, Use of vitamin K antagonist anticoagulation. Mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial. Combined organ transplantation. Re-transplantation. Patients that are dialysis-dependent prior to the liver transplantation.
Primary purpose
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Interventional model
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10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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