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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name CAPITL

NCTNCT02251041 (opens ClinicalTrials.gov in a new tab)Other idCAPITL RCT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
143 participants (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Design
Randomized · Single masking
Countries
1 country

Belgium

Start
Sept 2014
Primary completion
Feb 2019
Completion
Aug 2019
First posted
26 Sept 2014 (estimated)
Last update posted
23 Aug 2024
Conditions
Reperfusion Injury

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017201820192020
  1. Ph 2

    CAPITL

    NCT02251041

    Sept 2014 to Aug 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Antithrombin-IIIDrug
  • InfliximabDrug
  • ApotransferrinDrug
  • Human recombinant erythropoietinDrug
  • C1-InhibitorDrug
  • GlutathioneDrug
  • Alfa-tocopherolDrug
  • MelatoninDrug
  • EpoprostenolDrug
  • Sodium chloride solutionDrug

Arms2

  • Active comparator

    cases

    the group receives a combination of drugs

  • Placebo comparator

    controls

    the group do not receive a combination of drugs, but a placebo (sodium chloride solution)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Peak Aspartate Aminotransferase Within First 72h Post Transplant

    Time frame · within 72 hours following liver transplantation

    Registry description

    peak AST is defined as the highest value of serum AST within 72 hours following liver transplantation

Secondary outcomes(10)

  1. Graft Loss

    Time frame · 3 and 12 months after liver transplantation

    Registry description

    graft loss at 3 and 12 months after liver transplantation

  2. Recipient Death

    Time frame · 3 and 12 months after liver transplantation

    Registry description

    recipient death at 3 and 12 months after liver transplantation

  3. Early Graft Dysfunction

    Time frame · within first 7 days

    Registry description

    early graft dysfunction as defined by Olthoff

  4. Number of Participants Developing Biliary Strictures

    Time frame · within 12 months post transplantation

    Registry description

    Biliary strictures are the narrowing of the intrahepatic or extrahepatic biliary ductal system. Here we report the number of participants developing biliary strictures within 12 months post transplantation by MRCP (magnetic resonance cholangiopancreatography)

  5. Ischemia Reperfusion Injury Score

    Time frame · One hour post reperfusion

    Registry description

    Ischemia Reperfusion Injury score 1h post reperfusion by using the Suzuki score and Monbaliu et al. The score ranges from 0 (no injury) to 4 (severe injury).

  6. Graft Rejection

    Time frame · till 1 year after transplantation

    Registry description

    a liver biopsy will be taken after transplantation and in case of clinical suspicion of acute rejection

  7. Patients With at Least 1 Severe Surgical Complications

    Time frame · within 1 year after liver transplantation

    Registry description

    The ranking of surgical complications will be done by using Clavien-Dindo classification Grade I Any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. This includes the need for certain drugs (e.g. antiemetics, antipyretics, analgesics, diuretics and electrolytes), treatment with physiotherapy and wound infections that are opened at the bedside Grade II Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III Complications requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complications; this includes CNS complications (e.g. brain haemorrhage, ischaemic stroke, subarachnoid haemorrhage) which require intensive care, but excludes transient ischaemic attacks (TIAs) Grade V Death of the patient A severe surgical complication is defined as Grade III or higher.

  8. Non-anastomotic Biliary Stricture

    Time frame · 1 year

    Registry description

    Non-anastomotic biliary stricture at 1 year

  9. Acute Kidney Injury Score

    Time frame · 48h

    Registry description

    An acute kidney injury score of 1 indicates risk; 2, injury; and 3, failure. According to RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) Minimum score is 0 meaning there is no injury, maximum score is 3 meaning failure of the organ.

  10. Post-Reperfusion Syndrome

    Time frame · first 5 minutes following graft reperfusion

    Registry description

    Post-reperfusion syndrome defined as a 30% decrease of mean systemic blood pressure for more than 1 minute during the first 5 minutes following graft reperfusion

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· within 72 hours following liver transplantation

Peak Aspartate Aminotransferase Within First 72h Post Transplant

GroupValue (U/L)
Combined Drug Approach1262.9
Controles1451.2
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 3 and 12 months after liver transplantation

Graft Loss

GroupValue (Participants)
Combined Drug Approach2
Controles0
Secondary outcomeCount of participants· 3 and 12 months after liver transplantation

Recipient Death

GroupValue (Participants)
Cases3
Controles1
Secondary outcomeCount of participants· within first 7 days

Early Graft Dysfunction

GroupValue (Participants)
Cases13
Controles17
Secondary outcomeCount of participants· within 12 months post transplantation

Number of Participants Developing Biliary Strictures

GroupValue (Participants)
Combined Drug Approach13
Controles10
Secondary outcomeMedian· One hour post reperfusion

Ischemia Reperfusion Injury Score

GroupValue (score)
Combined Drug Approach2
Controles2
Secondary outcomeCount of participants· till 1 year after transplantation

Graft Rejection

GroupValue (Participants)
Combined Drug Approach9
Controles8
Secondary outcomeCount of participants· within 1 year after liver transplantation

Patients With at Least 1 Severe Surgical Complications

GroupValue (Participants)
Combined Drug Approach10
Controles8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Combined Drug Approachthe group receives a combination of drugs Antithrombin-III Infliximab Apotransferrin Human recombinant erythropoietin C1-Inhibitor Glutathione Alfa-tocopherol Melatonin Epoprostenol4 / 366 / 3633 / 36
Controlesthe group do not receive a combination of drugs, but a placebo (sodium chloride solution) Sodium chloride solution3 / 364 / 3631 / 36

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedMeurisse N, Mertens M, Fieuws S, Gilbo N, Jochmans I, Pirenne J, Monbaliu D. Effect of a Combined Drug Approach on the Severity of Ischemia-Reperfusion Injury During Liver Transplant: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230819. doi: 10.1001/jamanetworkopen.2023.0819. PMID 36853611

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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