Trial · NCT02251041
Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)
NCT02251041, Phase 2, Completed, Universitaire Ziekenhuizen KU Leuven; results first posted 2024-08-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL). Trials, record NCT02251041. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02251041
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)
- NCT number
- NCT02251041
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 143 participants, actual
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Conditions
- Reperfusion Injury
- Interventions
- Antithrombin-III, Infliximab, Apotransferrin, Human recombinant erythropoietin, C1-Inhibitor, Glutathione, Alfa-tocopherol, Melatonin, Epoprostenol, Sodium chloride solution
- First posted
- 2014-09-26
- Last updated
- 2024-08-23
- Results first posted
- 2024-08-23
- Limitations and caveats
* Single center RCT~* Individual effects of each component of CDA in decreasing IRI were not assessed separately.~* Despite the fact that CDA components were administrated according to a specific timing in relation to their pharmacokinetics with the aim to reach a peak concentration during reperfusion, blood levels of each component were not determined.~* Although the study was powered to detect differences in peak AST, the small sample size did not allow a claim on the absence of an effect.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Aspartate Aminotransferase Within First 72h Post Transplant | within 72 hours following liver transplantation | peak AST is defined as the highest value of serum AST within 72 hours following liver transplantation |
| Secondary | Graft Loss | 3 and 12 months after liver transplantation | graft loss at 3 and 12 months after liver transplantation |
| Secondary | Recipient Death | 3 and 12 months after liver transplantation | recipient death at 3 and 12 months after liver transplantation |
| Secondary | Early Graft Dysfunction | within first 7 days | early graft dysfunction as defined by Olthoff |
| Secondary | Number of Participants Developing Biliary Strictures | within 12 months post transplantation | 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) |
| Secondary | Ischemia Reperfusion Injury Score | One hour post reperfusion | 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). |
| Secondary | Graft Rejection | till 1 year after transplantation | a liver biopsy will be taken after transplantation and in case of clinical suspicion of acute rejection |
| Secondary | Patients With at Least 1 Severe Surgical Complications | within 1 year after liver transplantation | 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. |
| Secondary | Non-anastomotic Biliary Stricture | 1 year | Non-anastomotic biliary stricture at 1 year |
| Secondary | Acute Kidney Injury Score | 48h | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peak Aspartate Aminotransferase Within First 72h Post Transplant | within 72 hours following liver transplantation | U/L | GEOMETRIC_MEAN | |
| SECONDARY | Graft Loss | 3 and 12 months after liver transplantation | Death-censored graft survival | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Recipient Death | 3 and 12 months after liver transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Early Graft Dysfunction | within first 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Developing Biliary Strictures | within 12 months post transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Ischemia Reperfusion Injury Score | One hour post reperfusion | score | MEDIAN | |
| SECONDARY | Graft Rejection | till 1 year after transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patients With at Least 1 Severe Surgical Complications | within 1 year after liver transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Non-anastomotic Biliary Stricture | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Acute Kidney Injury Score | 48h | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Peak Aspartate Aminotransferase Within First 72h Post Transplant | Combined Drug Approach | 1262.9 | 95% Confidence Interval 946.3 to 1685.4 | U/L | |
| Peak Aspartate Aminotransferase Within First 72h Post Transplant | Controles | 1451.2 | 95% Confidence Interval 1087.4 to 1936.7 | U/L | |
| Graft Loss | Combined Drug Approach | 3-months | 2 | Participants | |
| Graft Loss | Controles | 3-months | 0 | Participants | |
| Graft Loss | Combined Drug Approach | 12-months | 3 | Participants | |
| Graft Loss | Controles | 12-months | 0 | Participants | |
| Recipient Death | Cases | 3 months | 3 | Participants | |
| Recipient Death | Controles | 3 months | 1 | Participants | |
| Recipient Death | Cases | 12 months | 4 | Participants | |
| Recipient Death | Controles | 12 months | 3 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combined Drug Approach | 53 | |
| Overall Study | STARTED | Controles | 40 | |
| Overall Study | COMPLETED | Combined Drug Approach | 38 | |
| Overall Study | COMPLETED | Controles | 36 | |
| Overall Study | NOT COMPLETED | Combined Drug Approach | 15 | |
| Overall Study | NOT COMPLETED | Controles | 4 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Post-operative delirium | General disorders | Combined Drug Approach | 9 | 36 | |
| other | Post-operative delirium | General disorders | Controles | 11 | 36 | |
| other | Acute kidney injury | Renal and urinary disorders | Combined Drug Approach | 12 | 36 | |
| other | Acute kidney injury | Renal and urinary disorders | Controles | 9 | 36 | |
| other | Respiratory failure post-op | Respiratory, thoracic and mediastinal disorders | Combined Drug Approach | 1 | 36 | |
| other | Respiratory failure post-op | Respiratory, thoracic and mediastinal disorders | Controles | 4 | 36 | |
| other | Urinary tract infections | Renal and urinary disorders | Combined Drug Approach | 2 | 36 | |
| other | Urinary tract infections | Renal and urinary disorders | Controles | 5 | 36 | |
| other | De novo diabetes mellitus | Endocrine disorders | Combined Drug Approach | 3 | 36 | |
| other | De novo diabetes mellitus | Endocrine disorders | Controles | 2 | 36 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combined Drug Approach | 4 | 36 |
| Total, all-cause mortality | Controles | 3 | 36 |
| Total, other adverse events | Combined Drug Approach | 33 | 36 |
| Total, other adverse events | Controles | 31 | 36 |
| Total, serious adverse events | Combined Drug Approach | 6 | 36 |
| Total, serious adverse events | Controles | 4 | 36 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Combined Drug Approach vs Controles: Patients With at Least 1 Severe Surgical Complications | Trial comparisons |
| Combined Drug Approach vs Controles: Number of Participants Developing Biliary Strictures | Trial comparisons |
| Combined Drug Approach vs Controles: Post-Reperfusion Syndrome | Trial comparisons |
| Combined Drug Approach vs Controles: Graft Rejection | Trial comparisons |
| Cases vs Controles: Early Graft Dysfunction | Trial comparisons |
| Combined Drug Approach vs Controles: Non-anastomotic Biliary Stricture | Trial comparisons |
| Combined Drug Approach vs Controles: deaths from any cause | Trial comparisons |
| Combined Drug Approach vs Controles: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02251041
GET https://conductscience.org/api/trials/v1/NCT02251041/results?page=2