drugset / Trial / NCT02429453
FFP Versus PCC in Intracranial Hemorrhage
Withdrawn
University of Utah
RandomizedParallel-groupOpen-labelTreatment
Summary
The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.
Timeline
- Start
- 2015-04
- Primary completion
- 2016-03
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | 2 unknown | — |
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | 3 unknown | — |
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | 4 unknown | — |
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | 5 unknown | — |
| Comparator | Fresh Frozen Plasma | Protein / enzyme biologic | 6 unknown | — |
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 25 unknown | — |
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 35 unknown | — |
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 50 unknown | — |