Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers

Study Overview
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Brief Summary
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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.

Official Title
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Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL): a First-in-men Study

Conditions
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Reperfusion Injury

Intervention / Treatment
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* Drug: Antithrombin-III
* Drug: Infliximab
* Drug: Apotransferrin
* Drug: Human recombinant erythropoietin
* Drug: C1-Inhibitor
* Drug: Glutathione
* Drug: Alfa-tocopherol
* Drug: Melatonin
* Drug: Epoprostenol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined drug approach, safety study<br> | Drug: Antithrombin-III<br> <br> Drug: Infliximab<br> <br> Drug: Apotransferrin<br> <br> Drug: Human recombinant erythropoietin<br> <br> Drug: C1-Inhibitor<br> <br> Drug: Glutathione<br> <br> Drug: Alfa-tocopherol<br> <br> Drug: Melatonin<br> <br> Drug: Epoprostenol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | During and within the 7 days following the liver transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver, Transplantation, Ischemia-reperfusion, Safety