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 (PROCRITÂ®) as compared to patients receiving standard of care blood conservation management.

Timeline

Start: 1998-04
Primary completion: —
Completion: 2006-05

Outcome

Missed primary endpoint

paper The between-group difference was 2.6% (97.5% upper confidence limit, 5.4%). PMID 19927096 ↗

Publications

Stowell CP, Jones SC, Enny C, Langholff W, Leitz G. An open-label, randomized, parallel-group study of perioperative epoetin alfa versus standard of care for blood conservation in major elective spinal surgery: safety analysis. Spine (Phila Pa 1976). 2009 Nov 1;34(23):2479-85. doi: 10.1097/BRS.0b013e3181bd163f.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	epoetin alfa	Protein / enzyme biologic	600 iu/kg	Subcutaneous