Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
NCT ID: NCT00668031
Last Updated: 2014-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
359 participants
INTERVENTIONAL
2005-02-28
2006-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm 1
Trasylol (Aprotinin, BAYA0128)
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump
Arm 2
Placebo
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump
Interventions
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Trasylol (Aprotinin, BAYA0128)
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump
Placebo
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump
Eligibility Criteria
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Inclusion Criteria
* Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
La Jolla, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Farmington, Connecticut, United States
Bay Pines, Florida, United States
Jacksonville Beach, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
Mooresville, Indiana, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Worcester, Massachusetts, United States
Kalamazoo, Michigan, United States
Ypsilanti, Michigan, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Bend, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Lubbock, Texas, United States
San Antonio, Texas, United States
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Fredericton, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Guelph, Ontario, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Oshawa, Ontario, Canada
Oshawa, Ontario, Canada
Richmond Hill, Ontario, Canada
Québec, Quebec, Canada
San Juan, , Puerto Rico
Countries
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Other Identifiers
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11694
Identifier Type: -
Identifier Source: org_study_id