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)

This study has been completed.
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00211146
First received: September 13, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Anemia
Venous Thrombosis
Drug: epoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Parallel-Group Study to Confirm the Safety and Efficacy of Epoetin Alfa (PROCRIT) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Subjects Undergoing Major Elective Spinal Surgery

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The incidence of DVT as determined by color flow duplex imaging

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

Enrollment: 680
Study Start Date: April 1998
Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211146

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ortho Biotech, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00211146     History of Changes
Other Study ID Numbers: CR004621
Study First Received: September 13, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia, erythropoetin, PROCRIT, deep vein thrombosis, thrombovascular event

Additional relevant MeSH terms:
Anemia
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014