Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure: a multicenter randomized trial (GRAFT-Trial)

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The acute on chronic liver failure (ACLF) is characterised by a severe deterioration of liver function due to a precipitating event (e.g. variceal bleeding, infection, alcohol consumption, viral hepatitis or druginduced toxicity) on top of an underlying chronic liver disease. As therapeutic options are limited the mortality rate lies between 40 and 80% at 3 months. The granulocyte colony-stimulating factor (G-CSF) mobilized stem- as well as immune cells and improved liver function in preclinical trials. In two recent small randomized studies, G-CSF treatment reduced the rate of infectious complications and significantly improved patients´ survival in acute on chronic liver failure. Thus, G-CSF is a promising treatment option that needs to be evaluated in a multi-centre controlled trial. The GRAFT trial will randomise a total of 292 patients with acute on chronic liver failure from 20 German centres between standard of care with and without G-CSF. All participants will be followed for 12 months in order to evaluate safety and efficacy of G-CSF. If successful, the GRAFT trial has the potential to change clinical practice in acute on chronic liver failure.