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

Primary Purpose

Reperfusion Injury

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Antithrombin-III
Infliximab
Apotransferrin
Human recombinant erythropoietin
C1-Inhibitor
Glutathione
Alfa-tocopherol
Melatonin
Epoprostenol
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reperfusion Injury focused on measuring Liver, Transplantation, Ischemia-reperfusion, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined drug approach, safety study

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Full Information

First Posted
June 21, 2013
Last Updated
September 24, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01886443
Brief Title
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers
Acronym
CAPITL
Official Title
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL): a First-in-men Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reperfusion Injury
Keywords
Liver, Transplantation, Ischemia-reperfusion, Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined drug approach, safety study
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Antithrombin-III
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Type
Drug
Intervention Name(s)
Apotransferrin
Intervention Type
Drug
Intervention Name(s)
Human recombinant erythropoietin
Intervention Type
Drug
Intervention Name(s)
C1-Inhibitor
Intervention Type
Drug
Intervention Name(s)
Glutathione
Intervention Type
Drug
Intervention Name(s)
Alfa-tocopherol
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Type
Drug
Intervention Name(s)
Epoprostenol
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
During and within the 7 days following the liver transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diethard Monbaliu, MD, PhD
Organizational Affiliation
Abdominal transplant surgery - transplant coordination, Abdominal transplant surgery lab (microbiology & immunology Dpt)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
19826248
Citation
Monbaliu D, Vekemans K, Hoekstra H, Vaahtera L, Libbrecht L, Derveaux K, Parkkinen J, Liu Q, Heedfeld V, Wylin T, Deckx H, Zeegers M, Balligand E, Buurman W, van Pelt J, Porte RJ, Pirenne J. Multifactorial biological modulation of warm ischemia reperfusion injury in liver transplantation from non-heart-beating donors eliminates primary nonfunction and reduces bile salt toxicity. Ann Surg. 2009 Nov;250(5):808-17. doi: 10.1097/SLA.0b013e3181bdd787.
Results Reference
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PubMed Identifier
21987442
Citation
Vekemans K, Monbaliu D, Balligand E, Heedfeld V, Jochmans I, Pirenne J, van Pelt J. Improving the function of liver grafts exposed to warm ischemia by the Leuven drug protocol: exploring the molecular basis by microarray. Liver Transpl. 2012 Feb;18(2):206-18. doi: 10.1002/lt.22446.
Results Reference
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Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers

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