Status:
COMPLETED
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.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Blood Transfusion
Blood Transfusion, Autologous
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 shor...
Detailed Description
Patients undergoing surgery frequently require blood transfusions both during and after the operation. Patients often have their own blood collected for this purpose over a standard 3- to 4-week presu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 1991
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00270023
End Date
November 1 1991
Last Update
May 18 2011
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