Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban

Exclusion criteria

• ✕. Premature infants (corrected age \<37 weeks gestational age)
• ✕. Subjects undergoing Extracorporeal Membrane Oxygenation (ECMO) treatment
• ✕. Fibrinolytic therapy \<24 hours before enrollment
• ✕. Lumbar puncture or spinal/epidural catheter placement within the past 48 hours
• ✕. Severe hepatic impairment (Child-Pugh Class C) Note: in patients with suspected/confirmed severe liver disease, Child-Pugh C stage of liver disease must be excluded before start of treatment. For calculating Child-Pugh score, laboratory parameters in the patient file on INR, prothrombin time, serum albumin and total bilirubin taken can be taken, if they have been obtained within the last 48 hours before randomization. In all other patients these parameters have to be measured before start of treatment to identify potential exclusion criteria.
• ✕. Active bleeding
• ✕. Subjects with the following conditions to be excluded if alternative antithrombotic treatments are available:
• ✕. An unexplained activated partial thromboplastin time (aPTT) \> 2 x the normal range