drugset / Trial / NCT00211146
A Study to Confirm the Safety and Efficacy of Epoetin Alfa (PROCRIT) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Patients Undergoing Major Elective Spinal Surgery (SPINE Study)
Phase 3
Completed
680 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to investigate the incidence of deep vein thrombosis in patients receiving a perisurgical regimen of epoetin alfa (PROCRIT®) as compared to patients receiving standard of care blood conservation management.
Timeline
- Start
- 1998-04
- Primary completion
- —
- Completion
- 2006-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 600 iu/kg | Subcutaneous |