Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blood Loss, Surgical
Intervention: Trasylol (Aprotinin, BAYA0128) (Drug); Placebo (Drug)
Phase: Phase 3
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Percent of subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
The percent of subjects receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
The percent of subjects who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone.
The number of units of blood or packed red cells transfused per patient requiring transfusion.
The estimated blood loss during surgery, drainage (in milliliters) from the operative site in the first six hours post-operatively, and total drainage until removal of drains.
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusion
Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.
Changes in blood markers related to inflammation and blood coagulation
Minimum age: 18 Years.
Maximum age: N/A.
- Subjects requiring elective primary total hip replacement surgery
- Documented, signed, dated informed consent obtained prior to any study specific
procedures being performed
- 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
Locations and Contacts
Quebec G1L 3L5, Canada
San Juan 00935, Puerto Rico
Birmingham, Alabama 35205, United States
Mobile, Alabama 36608, United States
Edmonton, Alberta T6G 2B7, Canada
Phoenix, Arizona 85023, United States
Kelowna, British Columbia V1Y 1T2, Canada
Vancouver, British Columbia V6Z 1Y6, Canada
La Jolla, California 92037, United States
San Diego, California 92123, United States
Aurora, Colorado 80012, United States
Farmington, Connecticut 06032, United States
Bay Pines, Florida 33744, United States
Jacksonville Beach, Florida 32250, United States
Sarasota, Florida 34239, United States
St. Petersburg, Florida 33703, United States
Boise, Idaho 83702, United States
Indianapolis, Indiana 46260, United States
Mooresville, Indiana 46158, United States
Iowa City, Iowa 52242-1089, United States
Baltimore, Maryland 21215, United States
Worcester, Massachusetts 01655, United States
Kalamazoo, Michigan 49009, United States
Ypsilanti, Michigan 48197, United States
Fredericton, New Brunswick E3B 5N5, Canada
Durham, North Carolina 27710, United States
Greensboro, North Carolina 27401, United States
Halifax, Nova Scotia B3H 3A7, Canada
Guelph, Ontario N1E 4J4, Canada
Kitchener, Ontario N2G 1G3, Canada
London, Ontario N6A 5A5, Canada
Oshawa, Ontario L1G 2B9, Canada
Oshawa, Ontario L1J 2J2, Canada
Richmond Hill, Ontario L4C 4Z3, Canada
Bend, Oregon 97701, United States
Philadelphia, Pennsylvania 19107, United States
Pittsburgh, Pennsylvania 15213-2592, United States
Dallas, Texas 75231, United States
Lubbock, Texas 79410, United States
San Antonio, Texas 78233, United States
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Starting date: February 2005
Last updated: December 26, 2014