Trial Condition(s):

Blood Loss, Surgical

Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer

Bayer Identifier:

11800

ClinicalTrials.gov Identifier:

NCT00306137

EudraCT Number:

Not Available

Terminated/Withdrawn

Trial Purpose

Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.

Inclusion Criteria
- Men or women 18 years of age and older
 - Subjects requiring protocol specified oncological surgery. Subjects must have histological confirmation of malignancy in lung or esophagus
 - Documented, signed and 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 undergoing laparoscopic surgery
 - Subjects with sepsis or mesothelioma
 - 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
104
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

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15213-2592

Status
Completed
 
Locations

University of Virginia Health System

Charlottesville, United States, 22908

Status
Completed
 
Locations

M. D. Anderson Cancer Center - University of Texas

Houston, United States, 77030

Status
Completed
 
Locations

Emory University School of Medicine

Atlanta, United States, 30322

Status
Completed
 
Locations

CorVasc, MDs, PC

Indianapolis, United States, 46260

Status
Completed
 
Locations

Brigham & Women's Hospital

Boston, United States, 02115-6195

Status
Completed
 
Locations

Medical College of Georgia

Augusta, United States, 30912

Status
Completed
 
Locations

University Hospitals Case Medical Center

Cleveland, United States, 44106-2602

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, Australia

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, Belgium

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, Spain

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, France

Status
Terminated
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Completed
 
Locations

Indiana University Hospital

Indianapolis, United States, 46202

Status
Completed
 
Locations

Barnes-Jewish Hospital

St. Louis, United States, 63110-1094

Status
Completed
 
Locations

University of Utah

Salt Lake City, United States, 84108

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, Austria

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, Canada

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, Germany

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, Denmark

Status
Completed
 
Locations

Bayer Clinical Research Center

ask Contact, United Kingdom

Status
Terminated
 

Trial Design