drugset / Trial / NCT00618098
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
Timeline
- Start
- 2008-05
- Primary completion
- 2012-03
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | 5 ml | Intravenous |
| Subject | Octaplex | Protein / enzyme biologic | — | Intravenous |
Indications
No indication recorded.