Status:
COMPLETED
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)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Anemia
Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The objective of the study is to demonstrate that there is no clinically important additional risk for deep vein thrombosis (DVT) in adult spine surgery using a perisurgical regimen of epoetin alfa (P...
Eligibility Criteria
Inclusion
- Subjects scheduled for elective spinal surgery (with a minimum of 3-weeks lead time) with significant anticipated perioperative blood loss (2-4 units of blood)
- Hemoglobin \>10 and \< 13 g/dL at screening
- Female subjects must be post menopausal for at least one year, surgically incapable of childbearing (hysterectomy or tubal ligation), or practicing an acceptable method of birth control (e.g., hormonal contraceptives, intrauterine devices, or barrier and spermicide). The subject should continue with the same method for the duration of the study. If a female subject is practicing an acceptable method of birth control, she must have maintained her normal menstrual pattern within the three months prior to study entry
- No clinically significant abnormal hematologic or serum chemistry values. Negative serum pregnancy test for female subjects not post menopausal for at least one year or surgically incapable of childbearing (hysterectomy or tubal ligation)
Exclusion
- No primary hematologic disease
- No clinically significant disease/dysfunction of the cardiovascular (NYHA Classification Class II-IV), neurologic (cerebral), pulmonary, endocrine, gastrointestinal, or genitourinary systems, which in the opinion of the investigator would put the subject at increased risk for a thrombovascular event, compromise the subject's ability to respond to r-HuEPO therapy, or otherwise impair their ability to participate in this study
- No history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- No subjects who are to receive perioperative pharmacologic anticoagulation (e.g., coumadin, heparin, lovenox, aspirin/ASA)
- No subjects prohibited from receiving blood transfusions
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT00211146
Start Date
April 1 1998
End Date
May 1 2006
Last Update
June 10 2011
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