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

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: NCT02251041
• Other study ID #: CAPITL RCT
• Status: Completed
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: August 2019

Study information

• Verified date: December 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, glutathione, alfa-tocopherol, melatonin and epoprostenol)aimed to reduce ischemia-reperfusion injury during liver transplantation in eligible recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• 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,

• 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.

Related Conditions & MeSH terms

• Ischemia
• Reperfusion Injury
• Wounds and Injuries

Intervention

Drug:
• Antithrombin-III

• Infliximab

• Apotransferrin

• Human recombinant erythropoietin

• C1-Inhibitor

• Glutathione

• Alfa-tocopherol

• Melatonin

• Epoprostenol

• Sodium chloride solution

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	log-transformed peak AST	log-transformed peak AST, where peak AST is defined as the highest value of serum AST within 72 hours following liver transplantation	within 72 hours following liver transplantation
Secondary	graft loss	graft loss at 3 and 12 months after liver transplantation	3 and 12 months after liver transplantation
Secondary	recipient death	recipient death at 3 and 12 months after liver transplantation	3 and 12 months after liver transplantation
Secondary	early graft dysfunction	early graft dysfunction as defined by Olthoff	within first 7 days
Secondary	Incidence of biliary strictures	Incidence of biliary strictures within 12 months post transplantation by MRCP (magentic resonance cholangiopancreatography)	within 12 months post transplantation
Secondary	IRI score	IRI score during transplantation, 1 week and 1 year after liver transplantation by using the Suzuki score and Monbaliu et al.	during transplantation, 1 week and 1 year after
Secondary	Graft rejecton	a liver biopsy will be taken after transplantation and in cas of clinical suspicion of acute rejection	till 1 year after transplantation
Secondary	Surgical complications	the ranking of surgical complications will be done by using Clavien-Dindo classification	within 30 days after liver transplantation