drugset / Trial / NCT00102037
Use of Activated Recombinant FVII in Spinal Surgery
RandomizedSingle-groupDouble-blindTreatment
Summary
This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.
Timeline
- Start
- 2004-07
- Primary completion
- 2006-02
- Completion
- 2006-02
Publications
- Results Sachs B, Delacy D, Green J, Graham RS, Ramsay J, Kreisler N, Kruse P, Khutoryansky N, Hu SS. Recombinant activated factor VII in spinal surgery: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2285-93. doi: 10.1097/BRS.0b013e3181557d45.
- Results Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 30 ug/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 60 ug/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 120 ug/kg | — |