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)

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211146
• Other study ID #: CR004621
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 8, 2011
• Start date: April 1998
• Est. completion date: May 2006

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• epoetin alfa

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Ortho Biotech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of DVT as determined by color flow duplex imaging
Secondary	Incidence of TVEs; Proportion of completed subjects receiving allogeneic red cell transfusions; Change in hemoglobin and hematocrit from baseline to end of study

External 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