Overview

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

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universitaire Ziekenhuizen Leuven
Treatments:
alpha-Tocopherol
Antithrombin III
Antithrombins
Epoetin Alfa
Epoprostenol
Infliximab
Melatonin
Tezosentan
Tocopherols
Vitamin E
Criteria
Inclusion Criteria:

1. Patients suffering from irreversible liver failure eligible for liver transplantation
according to Eurotransplant guidelines.

2. Patients > 18 years of age at time of listing on Eurotransplant waiting list for liver
transplantation in University Hospitals Leuven, Belgium.

Exclusion Criteria:

1. Patients who refuse to participate in the study.

2. History of hypersensitivity to one/several component(s) of the combined drug approach.

3. 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.

4. Mental conditions rendering the subject incapable to understand the nature, scope, and
consequences of the trial.

5. Combined organ transplantation.

6. Re-transplantation.

7. Patients that are dialysis-dependent prior to the liver transplantation.