Table 1.
Exclusion criteria of HEPATICUS-1 and of HEPATICUS-2 trial
| Exclusion criteria for both HEPATICUS-1 and HEPATICUS-2 | |
|---|---|
| Patients, whose mortality approaches 100%, or who are not likely to benefit from treatment (intervention with ADVOS is likely to be futile) | |
| Patients, whose current medical condition does not allow treatment with any extracorporeal procedure | |
| Potential conflict with good clinical practice (GCP) or with the declaration of Helsinki | |
| PaO2/FiO2 ≤ 100 mmHg (respiratory SOFA score of 4) | |
| Patient testament excludes the use of life-prolonging measures | |
| Post-operative patients whose liver failure is related to liver surgery | |
| Participation in another clinical study | |
| Patients diagnosed with Creutzfeldt-Jakob disease | |
| Pregnancy | |
| Weight ≥120 kg | |
| Uncontrolled seizures | |
| Mean arterial pressure ≤50 mmHg despite conventional medical treatment | |
| Active or uncontrolled bleeding | |
| Untreatable extrahepatic cholestasis | |
| Patients with MELD-score of 40 | |
| Exclusion criteria specific for HEPATICUS-1 | Exclusion criteria specific for HEPATICUS-2 |
| Patients with creatinine >5 mg/dl or urine output <200 ml/day (renal SOFA-score of 4) |
Patient with known history of chronic liver disease |
| Patients who receive a vasopressor support of Dopamine >15 μg/kg/min or epinephrine >0.1 μg/kg/min or norepinephrine >0.1 μg/kg/min (cardiovascular SOFA-score of 4) | |