Study identification

EU PAS number

EUPAS6769

Study ID

49929

Official title and acronym

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

DARWIN EU® study

No

Study countries

France

Study description

The first SALT (Study of Acute Liver Transplant) study was a retrospective, multicentre, multi-country study of drug-exposed ALF registered for liver transplantation (ALFT), over the years 2005-2007. In the 52 contributing centres in seven participating European countries, 9479 patients were registered for transplantation, 600 for ALF, of which 302 without clinical aetiology were exposed to a drug within 30 days, the most commonly found being paracetamol, even without overdose. The SALT-I study created a network of these liver transplant centres in seven European countries. It also accumulated a considerable body of data on drug-exposed acute liver failure in Europe. The main objective of SALT-I concerned only the risks associated with NSAIDs. The SALT-II study extended the retrospective part of SALT to 2008-2013, thus increasing its power. In the 21 French contributing centres, 559 ALFT patients were identified, of which 214 without clinical aetiology exposed to a drug within 30 days, the most commonly found being paracetamol, even without overdose (as for SALT-I). This SALT-III study took advantage of this network of liver transplantation centres to do a prospective case-population surveillance of liver transplantations for drug-related ALF. The prospective nature of the SALT-III study had to allow for better quality data acquisition for drug-related liver transplantation, within a systematic alert system. The objective was to build a surveillance network of liver transplant centres in France that provide real-time assessment of emerging risks related to drugs newly introduced to the market, allowing for earlier signal identification of a major drug-related public health issue. SALT-III was conducted in 17 French liver transplantation centres over the years 2015-2016. Because of difficulties for including prospectively eligible patients (emergency medical care), it was decided to retrospectively include eligible ALFT patients not identified in time.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 17 centres are involved in the study

Contact details

Nicholas MOORE

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Non-for-profit organisation (e.g. charity)

More details on funding

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable