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)

NCT ID: NCT00211146

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-04-30
• Study Completion Date: 2006-05-31

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 blood conservation management.

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 (PROCRIT®) versus the standard of care for blood conservation. Spine surgery was selected as the population to study because anti-coagulant therapy is not always administered in association with this surgery type. In addition, the efficacy of epoetin alfa (PROCRIT®) in protecting patients from receiving allogeneic red cell transfusion across adult spinal procedures will be studied. Patients scheduled for elective spinal surgery, who agree to participate in the study, and meet eligibility criteria will be randomly assigned to epoetin alfa (PROCRIT®) or standard of care. No perioperative anti-coagulation therapy is to be administered during the study. The study hypothesis is that there is no increased risk of DVT in patients receiving perisurgical epoetin alfa (PROCRIT®) treatment. Epoetin alfa (PROCRIT®) 600U/kg administered once per week for 3 weeks prior to surgery and on the day of surgery.

Conditions

Anemia; Venous Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

epoetin alfa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Principal Investigators

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

Role: STUDY_DIRECTOR

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

References

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.

Reference Type: DERIVED

PMID: 19927096 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=608&filename=CR004621_CSR.pdf

An Open-Label, Randomized, Parallel Group Study to Confirm the Safety and Efficacy of PROCRIT (Epoetin alfa) Administered Perioperatively Versus the Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery

Other Identifiers

CR004621

Identifier Type: -

Identifier Source: org_study_id