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

Reperfusion Injury Clinical Trial

— CAPITL  

Official title:

Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL): a First-in-men Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886443
• Other study ID #: CAPITL safety
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2013
• Last updated: September 24, 2014
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Reperfusion Injury

Intervention

Drug:
• Antithrombin-III

• Infliximab

• Apotransferrin

• Human recombinant erythropoietin

• C1-Inhibitor

• Glutathione

• Alfa-tocopherol

• Melatonin

• Epoprostenol

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		During and within the 7 days following the liver transplantation	Yes