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

U

Universitaire Ziekenhuizen KU Leuven

Status and phase

Completed
Phase 1

Conditions

Reperfusion Injury

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01886443
CAPITL safety

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

10 participants in 1 patient group

Combined drug approach, safety study
Experimental group
Treatment:
Drug: Melatonin
Drug: Human recombinant erythropoietin
Drug: C1-Inhibitor
Drug: Glutathione
Drug: Infliximab
Drug: Antithrombin-III
Drug: Epoprostenol
Drug: Alfa-tocopherol
Drug: Apotransferrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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