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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)

NCT00211146 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2011-06-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

epoetin alfa

Sponsors & Collaborators

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-04-30
Completion
2006-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211146 on ClinicalTrials.gov