Overview

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

Status:
Completed

Trial end date:
2019-08-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to establish the effectiveness 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 2

Accepts Healthy Volunteers?

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,

- 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.