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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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-listed for a first solitary full-size liver transplant were screened for eligibility. Exclusion criteria were acute liver failure, kidney failure, contraindication to treatment, participation in another trial, refusal, technical issues, and death while awaiting transplant. Included patients were enrolled and randomized at the time of liver offer. Data were analyzed from May 20, 2019, to May 27, 2020.

Participants were randomized to a combined drug approach with standard of care (static cold storage) or standard of care only (control group). In the combined drug approach group, following static cold preservation, donor livers were infused with epoprostenol (ex situ, portal vein); recipients were given oral α-tocopherol and melatonin prior to anesthesia and intravenous antithrombin III, infliximab, apotransferrin, recombinant erythropoietin-β, C1-inhibitor, and glutathione during the anhepatic and reperfusion phase.

The primary outcome was the posttransplant peak serum aspartate aminotransferase (AST) level within the first 72 hours. Secondary end points were the frequencies of postreperfusion syndrome, ischemia-reperfusion injury score, early allograft dysfunction, surgical complications, ischemic cholangiopathy, acute kidney injury, acute cellular rejection, and graft and patient survival.

Conditions

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Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cases

the group receives a combination of drugs

Group Type ACTIVE_COMPARATOR

Antithrombin-III

Intervention Type DRUG

Infliximab

Intervention Type DRUG

Apotransferrin

Intervention Type DRUG

Human recombinant erythropoietin

Intervention Type DRUG

C1-Inhibitor

Intervention Type DRUG

Glutathione

Intervention Type DRUG

Alfa-tocopherol

Intervention Type DRUG

Melatonin

Intervention Type DRUG

Epoprostenol

Intervention Type DRUG

controls

the group do not receive a combination of drugs, but a placebo (sodium chloride solution)

Group Type PLACEBO_COMPARATOR

Sodium chloride solution

Intervention Type DRUG

Interventions

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Antithrombin-III

Intervention Type DRUG

Infliximab

Intervention Type DRUG

Apotransferrin

Intervention Type DRUG

Human recombinant erythropoietin

Intervention Type DRUG

C1-Inhibitor

Intervention Type DRUG

Glutathione

Intervention Type DRUG

Alfa-tocopherol

Intervention Type DRUG

Melatonin

Intervention Type DRUG

Epoprostenol

Intervention Type DRUG

Sodium chloride solution

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No