Trial Condition(s):

Blood Loss, Surgical

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

Bayer Identifier:

11694

ClinicalTrials.gov Identifier:

NCT00668031

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 reasons

Trial Summary

Enrollment Goal
359
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Capstone Clinical Trials, Inc.

Birmingham, United States, 35205

Status
Completed
 
Locations

Colorado Orthopaedic Consultants, PC

Aurora, United States, 80012

Status
Completed
 
Locations

Intermountain Research Center

Boise, United States, 83702

Status
Terminated
 
Locations

Office of Dr. Paul Peters, Jr., MD

Dallas, United States, 75231

Status
Terminated
 
Locations

Orthopedic Associates of Hartford, PC

Farmington, United States, 06032

Status
Completed
 
Locations

Jacksonville Orthopaedic Institute

Jacksonville Beach, United States, 32250

Status
Completed
 
Locations

Coastal Clinical Research, Inc

Mobile, United States, 36608

Status
Completed
 
Locations

Kalamazoo Orthopedics Clinic

Kalamazoo, United States, 49009

Status
Completed
 
Locations

Michigan Orthopedic Center

Ypsilanti, United States, 48197

Status
Completed
 
Locations

St. Vincent Center for Joint Replacement

Indianapolis, United States, 46260

Status
Terminated
 
Locations

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15213-2592

Status
Completed
 
Locations

Orthopedic Medical Group

San Diego, United States, 92123

Status
Terminated
 
Locations

Office of Drs. Booth, Bartolozzi & Balderston, MDs

Philadelphia, United States, 19107

Status
Completed
 
Locations

University of Puerto Rico

San Juan, United States, 00935

Status
Terminated
 
Locations

All Florida Orthopaedic Associates

St. Petersburg, United States, 33703

Status
Completed
 
Locations

Sarasota Orthopedic Associates

Sarasota, United States, 34239

Status
Terminated
 
Locations

Unlimited Research, LP

San Antonio, United States, 78233

Status
Terminated
 
Locations

Gill Orthopedic Center

Lubbock, United States, 79410

Status
Completed
 
Locations

Scripps Clinic - Torrey Pines

La Jolla, United States, 92037

Status
Completed
 
Locations

Arizona Research Center, Inc.

Phoenix, United States, 85023

Status
Completed
 
Locations

Rothman Institute

Philadelphia, United States, 19107

Status
Completed
 
Locations

Center for Hip & Knee Surgery

Mooresville, United States, 46158

Status
Completed
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Terminated
 
Locations

University of Iowa Hospitals & Clinics

Iowa City, United States, 52242-1089

Status
Terminated
 
Locations

Sinai Hospital of Baltimore

Baltimore, United States, 21215

Status
Completed
 
Locations

The Center: Orthopedic & Neurosurgical Care and Research

Bend, United States, 97701

Status
Completed
 
Locations

Bay Pines VA Healthcare System

Bay Pines, United States, 33744

Status
Completed
 
Locations

Sports Medicine and Orthopaedics Center

Greensboro, United States, 27401

Status
Completed
 
Locations

Lubbock Sports Medicine

Lubbock, United States, 79410

Status
Terminated
 
Locations

University of Massachusetts Memorial Medical Center

Worcester, United States, 01655

Status
Completed
 
Locations

ADA Medical, Ltd.

Oshawa, Canada, L1J 2J2

Status
Completed
 
Locations

Lakeridge Health-Oshawa

Oshawa, Canada, L1G 2B9

Status
Completed
 
Locations

University of Alberta Hospital

Edmonton, Canada, T6G 2B7

Status
Completed
 
Locations

Guelph General Hospital

Guelph, Canada, N1E 4J4

Status
Terminated
 
Locations

Grand River Hospital

Kitchener, Canada, N2G 1G3

Status
Completed
 
Locations

St. Paul's Hospital - Vancouver

Vancouver, Canada, V6Z 1Y6

Status
Completed
 
Locations

Hopital St-Francois d'Assise-CHUQ

Quebec, Canada, G1L 3L5

Status
Completed
 
Locations

Dr. Everett Chalmers Hospital

Fredericton, Canada, E3B 5N5

Status
Terminated
 
Locations

Queen Elizabeth II Health Sciences Centre

Halifax, Canada, B3H 3A7

Status
Completed
 
Locations

London Health Sciences Centre

London, Canada, N6A 5A5

Status
Completed
 
Locations

Kelowna General Hospital

Kelowna, Canada, V1Y 1T2

Status
Terminated
 
Locations

York Central Hospital

Richmond Hill, Canada, L4C 4Z3

Status
Terminated
 

Trial Design