Study identification

EU PAS number

EUPAS5555

Study ID

40867

Official title and acronym

SALT-II: Study of Acute Liver Transplant Prolongation and continuation of the SALT-I study “A study of drug-exposed acute liver failure (ALF) in European transplant centres”

DARWIN EU® study

No

Study countries

France

Study description

The SALT-I study created a network of 55 liver transplant centres in seven European countries. It also accumulated a considerable body of data on drug-exposed acute liver failure in Europe. The national coordinators of these centres have expressed a desire to continue this collaboration and monitor severe acute hepatitis in Europe. Furthermore, the main objective of SALT-I concerned only the risks associated with NSAIDs. One of the main objectives of the SALT-II study is to assess the risks associated with other drugs than NSAID. The incidence of these very severe drug-induced acute liver failure is very low: we could identify only 40 cases associated with NSAIDs over 2005-2007, and fewer still with other drugs except paracetamol. To improve the precision of the measures of incidence, and to be able to identify emergent risks, it would seem desirable to increase the number of cases identified, by continuing the study for the next six years (2008-2013), and studying the possibility of expanding the network to other countries (Germany, Spain, Nordic or Eastern European countries).

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Sinem Ezgi Gulmez

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

Bordeaux University Foundation
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable