Study of Acute Liver Transplant-III: Prospective study of drug-exposed acute liver failure (ALF) in European liver transplant centers (SALT-III)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-population study

Study drug and medical condition

• Medical condition to be studied:
  Acute hepatic failure

  Liver transplant

Population studied

• Short description of the study population:
  The study involved adult patients undergone acute liver transplantation registered in the Study of Acute Liver Transplant (SALT) study identified from the European countries. ; ; The first SALT study, conducted from 2005-2007, involved 9479 patients with drug-exposed acute liver failure (ALFT) in seven European countries. The study gathered data on drug-exposed ALF and NSAID risks. The SALT-I and SALT-II studies expanded the network, identifying 559 ALFT patients in 21 French centers. The SALT-III study aimed to build a surveillance network for drug-related ALF, allowing real-time assessment of emerging risks and early signal identification of major public health issues. The study was conducted in 17 French liver transplantation centers from 2015-2016.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  120

Study design details

• Main study objective:
  To develop the network of liver transplant centres for the prospective identification of drug-related ALFT,To estimate the risk of drug-exposed ALFT in adults, in the 30 days prior to index date (ID, date of first symptoms), according to the population exposure to the same drugs provided by the national healthcare insurance system.
• Outcomes:
  The population event rate for all ALFT cases "without defined clinical cause" exposed to the drug(s) of interest within 30 days prior to ID, expressed as number of cases per million exposed patients over the 2-year study period. Event rates for ALFT “without defined clinical cause” exposed to the drug(s) of interest within 7, 15, or 90 days prior to ID.Event rates for ALFT “with a defined clinical cause”, exposed to drugs within 30 days prior to ID, compared to the previous event rates.Description of cases registered for hepatic transplantation after acute drug overdose.Identification of paracetamol adducts.
• Data analysis plan:
  Descriptive analysis,Exposure rates in ALFT were compared to the population exposure to the same drugs, provided by the national healthcare insurance system.The population event rate for all ALFT cases "without a defined clinical cause for ALFT" exposed to the drug(s) of interest within 30 days prior to index date were computed, globally and for each molecule of interest, with reference to person-time exposed (total population drug exposure) or to number of patients exposed for the 2-year period. The estimated rates (with 95% CI) were expressed in cases per million patient-years.