Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement

Completed · Phase 3 · Has a placebo group

Conditions studied: Blood Loss, Surgical

In brief

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 replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.

Key facts

Study ID

NCT00668031

Run by

Bayer

People needed

359

Starts

2005-02-01

Expected to finish

2006-01-01

Last updated by the study team

2014-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects requiring elective primary total hip replacement surgery
• Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Farmington, Connecticut, United States
• Study site — Bay Pines, Florida, United States
• Study site — Jacksonville Beach, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Boise, Idaho, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Mooresville, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Ypsilanti, Michigan, United States
• Study site — Durham, North Carolina, United States
• Study site — Greensboro, North Carolina, United States
• Study site — Bend, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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