The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
Planned cardiac surgery with CPB
Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
Patients between 18 and 85 years of age, inclusive
Freely given written or electronic informed consent
vitamin K antagonists (within 3 days)
direct oral anticoagulants (within 2 days)
thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment
ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment