Trial Condition(s):

Blood Loss, Surgical, Postoperative Hemorrhage

Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

Bayer Identifier:

12002

ClinicalTrials.gov Identifier:

NCT00306150

EudraCT Number:

2005-004055-35

Terminated/Withdrawn

Trial Purpose

The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

Inclusion Criteria
- Subjects 18 years of age and older
 - Subjects requiring elective radical or total cystectomy for bladder cancer
 - 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 or with a known or suspected allergy to aprotinin
 - Subjects with sepsis or undergoing laparoscopic surgery
 - Subjects with impaired renal function (serum creatinine >2.5 mg/dL or 221 micromoles/liter)
 - Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have
 - Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of <24% or hemoglobin of <8 g/dl)
 - Subjects who have participated in an investigational drug study within the past 30 days
 - Subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception
 - Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid
 - Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)

Trial Summary

Enrollment Goal
57
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Klinikum Großhadern der Ludwig-Maximilians-Universität

München, Germany, 81377

Status
Completed
 
Locations

Klinikum der Johannes-Gutenberg-Universität

Mainz, Germany, 55131

Status
Completed
 
Locations

Klinikum Fulda

Fulda, Germany, 36043

Status
Terminated
 
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66421

Status
Completed
 
Locations

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Status
Terminated
 
Locations

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15213-2592

Status
Completed
 
Locations

Vanderbilt University Medical School

Nashville, United States, 37232

Status
Terminated
 
Locations

Maine Medical Center

Portland, United States, 04102

Status
Terminated
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109-0330

Status
Terminated
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Terminated
 
Locations

University of Miami

Miami, United States, 33125

Status
Terminated
 
Locations

University of California, Los Angeles

Los Angeles, United States, 90095

Status
Terminated
 
Locations

University Hospitals Case Medical Center

Cleveland, United States, 44106-2602

Status
Terminated
 
Locations

University of North Carolina

Chapel Hill, United States, 27599-7065

Status
Terminated
 
Locations

University of Chicago

Chicago, United States, 60637

Status
Completed
 
Locations

University of Illinois at Chicago

Chicago, United States, 60612

Status
Terminated
 
Locations

Hôpital Pasteur - Nice

NICE, France, 06200

Status
Terminated
 
Locations

Hôpital Hôtel Dieu - Nantes Cedex

NANTES CEDEX, France, 44035

Status
Terminated
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Terminated
 
Locations

Universitetssjukhuset Lund

Lund, Sweden, 221 85

Status
Terminated
 
Locations

Klinikum der Universität Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Terminated
 
Locations

Freeman Hospital

Newcastle Upon Tyne, United Kingdom, NE7 7DN

Status
Terminated
 
Locations

Oklahoma University Health Science Center

Oklahoma City, United States, 73104

Status
Terminated
 
Locations

Columbus Urology Research, LLC

Columbus, United States, 43214-1419

Status
Completed
 
Locations

M. D. Anderson Cancer Center - University of Texas

Houston, United States, 77030

Status
Terminated
 
Locations

Fletcher Allen Health Care

Burlington, United States, 05401-1420

Status
Terminated
 
Locations

Johns Hopkins University School of Medicine

Baltimore, United States, 21224

Status
Terminated
 
Locations

Thomas Jefferson University

Philadelphia, United States, 19107

Status
Terminated
 
Locations

University of Colorado Health Sciences Center

Denver, United States, 80262

Status
Terminated
 
Locations

Baylor College of Medicine

Houston, United States, 77030

Status
Terminated
 
Locations

UZ Gent

GENT, Belgium, 9000

Status
Completed
 
Locations

Academisch Ziekenhuis Maastricht

MAASTRICHT, Netherlands, 6229 HX

Status
Completed
 
Locations

Universitetssjukhuset Linköping

Linköping, Sweden, 581 85

Status
Completed
 
Locations

Akademiska Sjukhuset

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Karolinska University Hospital

Stockholm, Sweden, 171 76

Status
Completed
 

Trial Design