A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
Recombinant Human Erythropoietin (R-HuEPO) in Non-Anemic Patients Scheduled for Selective Orthopedic and Vascular Surgery or Reductive Mammoplasty to Facilitate Presurgical Autologous Blood Donation Combined With Normo-Volemic Hemodilution (NVHD)
1 other identifier
interventional
112
0 countries
N/A
Brief Summary
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional 3-week blood donation period before surgery) in patients who are not anemic and who will be undergoing orthopedic, heart and blood vessel, or breast reduction surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production. Normovolemic hemodilution (NVHD, withdrawal of a patient's blood immediately before surgery, immediate replacement of blood with an equal volume of fluid, and return of the withdrawn blood after completion of surgery; a procedure which reduces the loss of blood during surgery) will also be performed.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for phase_2
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
November 1, 1991
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 26, 2005
CompletedMay 18, 2011
April 1, 2010
December 22, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of self-donated units of blood obtained within 11 days; Assessment of safety (laboratory tests, vital signs, and adverse events) from before the study to the end of the study
Secondary Outcomes (1)
Changes in hemoglobin, reticulocytes (immature red blood cells), and erythropoietin (red blood cell stimulating hormone) levels in blood from before the study to the end of the study
Interventions
Eligibility Criteria
You may qualify if:
- Patients scheduled for orthopedic surgery, heart and blood vessel surgery, or breast reduction surgery
- having an anticipated requirement of 3 or more units of blood
- who are non-anemic (hemoglobin within normal range of 12.0 - 18.0 grams/deciliter)
- having laboratory tests within normal ranges
You may not qualify if:
- Patients with history of any blood disease
- having signs and symptoms of significant disease/dysfunction
- having uncontrolled high blood pressure or signs and symptoms of significant dizziness, faintness, or lightheadedness which appear only on standing, and which are caused by low blood pressure
- who have received a blood transfusion within 1 month before the start of the study
- having a body weight \>100 kilograms (approximately 220 pounds)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Completion
November 1, 1991
Last Updated
May 18, 2011
Record last verified: 2010-04