Registry Protocol

International Acute Liver Failure Registry | IALFregistry.org

Background: Acute liver failure (ALF) occurs suddenly with severe dysfunction of the liver without previous illness of the liver. It can progress rapidly to multi-organ failure. Starting from the liver, it may affect different organ systems, along with hepatic encephalopathy and coagulopathy. In such severe cases, the mortality reaches up to 50% if emergent transplantation is not available.

Outcome data are available from developed countries, but outcomes in developing countries remain unknown. There is a need to collect data from all parts of the world, to create a single prospective registry and allow meaningful comparisons, as well as standardization of the procedure, across the globe.

 Center eligibility: Any center worldwide involved in treating and transplanting patients with ALF is eligible to participate in this registry. There is no minimum number of cases to be submitted or selection criteria for centers.

Team members: Each center may form a team of 3 members. Participants may include surgeons, anesthesiologists, hepatologists, critical care physicians, and other members involved in ALF. Auditors (data monitors) will be assigned to monitor the adherence to the registry protocol and the quality of data collection of the participating centers.

Inclusion criteria: All cases should be registered retrospectively or prospectively. Only primary cases with ALF should be implemented.

 

Exclusion criteria: ALF due to cardiac- and or hemodynamic shock, which leads secondary to liver failure

Outcomes: Morbidity and mortality until hospital discharge and up to 90 days postoperatively. Additional outcome data will be captured at 12 months follow-up.

 

Data ownership: ALFregistry.org will act as the custodian of the data. All participants can access their own submitted data without needing permission from the Executive Committees. The Chief Investigators, scientific, and Executive committees will decide about data sharing requests and will consider all such requests based on the quality and validity of the proposed project.

 

Data confidentiality: There will be no reporting of surgeon or center-related data; all data will be fully anonymized.

Authorship: All ALFregistry.org members who submit verified cases to the registry will be cited as group authors in the main publications. Spin-off studies may include formal named authorship but must include the “ALFregistry.org Collaborative” with group authorship for all participants.