Status: Recruiting
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
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)
Participants needed: 120
Trial details
Phase: Phase 3Age: 18-85Biological sex: AllType: InterventionalSponsor: OctapharmaUpdated: May 12, 2026Locations: 27
Eligibility criteria
Planned cardiac surgery with CPB [+4]
vitamin K antagonists (within 3 days) [+12]