Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
Octapharma
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)
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Planned cardiac surgery with CPB 2. 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) 3. Patients between 18 and 85 years of age, inclusive 4. Freely given written or electronic informed consent 5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery Exclusion Criteria: 1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start…