Status:
COMPLETED
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
Lead Sponsor:
Bayer
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip ...
Eligibility Criteria
Inclusion
- Subjects requiring elective primary total hip replacement surgery
- Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Exclusion
- Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, subject should be excluded. If during cardiac surgery in the last 6 months, there is a record of aprotinin administration, subject should be excluded
- Subjects with a known or suspected allergy to aprotinin - Subjects with impaired renal function (serum creatinine \> 3.5 mg/dl or 309 micromoles/liter)
- Subjects with a history of bleeding diathesis or known coagulation factor deficiency
- Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Subjects who refuse to receive allogenic blood products for religious or other reasons
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
359 Patients enrolled
Trial Details
Trial ID
NCT00668031
Start Date
February 1 2005
End Date
January 1 2006
Last Update
December 30 2014
Active Locations (40)
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1
Birmingham, Alabama, United States, 35205
2
Mobile, Alabama, United States, 36608
3
Phoenix, Arizona, United States, 85023
4
La Jolla, California, United States, 92037