PI: Jonel Trebicka (University of Bonn, Germany)
The PREDICT Study was designed to prospectively observe patients with cirrhosis and Acute Decompensation (AD) at risk of developing ACLF within three months, and to discover new clinical and laboratory predictors of ACLF development, patho-physiological mechanism (using prospective ancillary studies) and potential treatment to prevent ACLF.
The recruitment for the PREDICT Study was closed on the 31 of July 2018 and the last patient and last visit was on the 30 of October 2018. Finally, 47 centres included at least one patient. In total were recruited 1314 patients of which 732 patients had at inclusion CLIF-C AD score > 50 (Group 1), 374 patients a CLIC-C AD score ≤ 50 (Group 2) and 208 patients were recruited with ACLF at inclusion. These data numbers may change during the cleaning of the patients.
Currently, the Data Management Centre, together with the centres, are working constantly, in the cleaning of the patients and so far there are 896 patients clean, with 3802 recorded visits and sampling of biological material. In the PREDICT bio-bank there are located currently, more than 120.000 aliquots of different material. So far, the rate of development of ACLF in the patients of Group 1 and Group 2 is respectively 25% and 10%, with a median of 18.3%.
The mean time of ACLF-development was 14 days after inclusion. Moreover, at 90 days ca. 6% of the patients were transplanted and 17% of the patients died. These data are changing slightly with the increasing number of patients cleaned.
Overall, PREDICT study has been another example of successful collaboration within the European Academic centres and underlines the importance of the disease. We believe that this study will uncover major parts of currently unknown pathogenesis of development of ACLF and deliver important insight in potential therapeutic approaches of this disease.