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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

Status: Completed

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.

Clinical Details

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)

Secondary outcome:

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. Gender(s): Both.


Inclusion Criteria:

- Subjects requiring elective primary total hip replacement surgery

- Documented, signed, dated informed consent obtained prior to any study specific

procedures being performed Exclusion Criteria:

- 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

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Starting date: February 2005
Last updated: December 26, 2014

Page last updated: August 23, 2015

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