Status:
COMPLETED
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Reperfusion Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, glutathio...
Detailed Description
This unicentric, investigator-driven, open-label randomized clinical trial with 2 parallel arms was conducted in Belgium from September 2013 through February 2018, with 1-year follow-up. Adults wait-l...
Eligibility Criteria
Inclusion
- 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
- 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,
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT02251041
Start Date
September 1 2014
End Date
August 1 2019
Last Update
August 23 2024
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Belgium, 3000