Phase 2
N=93
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)
Reperfusion Injury
Bottom Line
View on ClinicalTrials.gov: NCT02251041 ↗Enrolled (actual)
93
Serious AEs
13.9%
Results posted
Aug 2024
Primary outcome: Primary: Peak Aspartate Aminotransferase Within First 72h Post Transplant — 1262.9; 1451.2 U/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Antithrombin-III (Drug); Infliximab (Drug); Apotransferrin (Drug); Human recombinant erythropoietin (Drug); C1-Inhibitor (Drug); Glutathione (Drug); Alfa-tocopherol (Drug); Melatonin (Drug); Epoprostenol (Drug); Sodium chloride solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Aspartate Aminotransferase Within First 72h Post Transplant |
1262.9; 1451.2 | — |
| SECONDARY Graft Loss |
2; 0; 3; 0 | — |
| SECONDARY Recipient Death |
3; 1; 4; 3 | — |
| SECONDARY Early Graft Dysfunction |
13; 17 | — |
| SECONDARY Number of Participants Developing Biliary Strictures |
13; 10 | — |
| SECONDARY Ischemia Reperfusion Injury Score |
2; 2 | — |
| SECONDARY Graft Rejection |
9; 8 | — |
| SECONDARY Patients With at Least 1 Severe Surgical Complications |
10; 8 | — |
| SECONDARY Non-anastomotic Biliary Stricture |
4; 2 | — |
| SECONDARY Acute Kidney Injury Score |
27; 31; 4; 1; 2; 3 | — |
| SECONDARY Post-Reperfusion Syndrome |
7; 6 | — |
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.
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,
- 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.
Data sourced from ClinicalTrials.gov (NCT02251041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.