drugset / Trial / NCT06096116
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
RandomizedParallel-groupTriple-blindTreatment
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)
Timeline
- Start
- 2024-08-21
- Primary completion
- 2028-03
- Completion
- 2028-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atenativ | Protein / enzyme biologic | 30 iu/kg | — |
| Subject | Atenativ | Protein / enzyme biologic | 60 iu/kg | — |