drugset / Trial / NCT06144125
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery
Phase 4
Recruiting
100 enrolled
Konkuk University Medical Center
Asan Medical Center · collabSoonchunhyang University Hospital · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for cardiac surgery.
Timeline
- Start
- 2026-03-27
- Primary completion
- 2026-09-30
- Completion
- 2026-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | — | Other |
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 10 iu/kg | — |
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 15 iu/kg | — |