Clinical Trial

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

Recruiting Phase 3
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Summary
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)
Protocol Amendment History 1 change
notable Trial sites expanded: 24 -> 27 locations 2026-05-13
Trial Details
NCT Number NCT06096116
Lead Sponsor Octapharma
Conditions Acquired Antithrombin Deficiency
Enrollment 120 participants
Start Date 2024-08-21
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-12