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 | Completed Phase 3

• 1 other identifier: CR004621
• Study Type: interventional
• Target: 680
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Venous Thrombosis

Keywords

Anemia, erythropoetin, PROCRIT, deep vein thrombosis, thrombovascular event

Outcome Measures

Primary Outcomes (1)

• The incidence of DVT as determined by color flow duplex imaging

Secondary Outcomes (1)

• Incidence of TVEs; Proportion of completed subjects receiving allogeneic red cell transfusions; Change in hemoglobin and hematocrit from baseline to end of study

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 19927096 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Anemia; Venous Thrombosis

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 1998
• Study Completion: May 1, 2006
• Last Updated: June 10, 2011

Record last verified: 2010-04