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Trial · NCT02251041

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPeak Aspartate Aminotransferase Within First 72h Post Transplantwithin 72 hours following liver transplantationpeak AST is defined as the highest value of serum AST within 72 hours following liver transplantation
SecondaryGraft Loss3 and 12 months after liver transplantationgraft loss at 3 and 12 months after liver transplantation
SecondaryRecipient Death3 and 12 months after liver transplantationrecipient death at 3 and 12 months after liver transplantation
SecondaryEarly Graft Dysfunctionwithin first 7 daysearly graft dysfunction as defined by Olthoff
SecondaryNumber of Participants Developing Biliary Strictureswithin 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)
SecondaryIschemia Reperfusion Injury ScoreOne hour post reperfusionIschemia 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).
SecondaryGraft Rejectiontill 1 year after transplantationa liver biopsy will be taken after transplantation and in case of clinical suspicion of acute rejection
SecondaryPatients With at Least 1 Severe Surgical Complicationswithin 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.
SecondaryNon-anastomotic Biliary Stricture1 yearNon-anastomotic biliary stricture at 1 year
SecondaryAcute Kidney Injury Score48h
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.
SecondaryPost-Reperfusion Syndromefirst 5 minutes following graft reperfusionPost-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
OtherIntensive Care Unit Length of Stay (Recipient)During hospital stay for liver transplantationIntensive Care Unit stay immediately after liver transplantation (not after rehospitalization)

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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