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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02251041
Other study ID # CAPITL RCT
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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