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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)

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia; Venous Thrombosis

Intervention: epoetin alfa (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Clinical Details

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

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

Primary outcome: The incidence of DVT as determined by color flow duplex imaging

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

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

Starting date: April 1998
Last updated: June 8, 2011

Page last updated: August 23, 2015

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