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

EU CT 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Terminated/Withdrawn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
Locations
Locations

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15213-2592

Locations

University of Virginia Health System

Charlottesville, United States, 22908

Locations

M. D. Anderson Cancer Center - University of Texas

Houston, United States, 77030

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Emory University School of Medicine

Atlanta, United States, 30322

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CorVasc, MDs, PC

Indianapolis, United States, 46260

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Brigham & Women's Hospital

Boston, United States, 02115-6195

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Medical College of Georgia

Augusta, United States, 30912

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University Hospitals Case Medical Center

Cleveland, United States, 44106-2602

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Bayer Clinical Research Center

ask Contact, Australia

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Bayer Clinical Research Center

ask Contact, Belgium

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Bayer Clinical Research Center

ask Contact, Spain

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Bayer Clinical Research Center

ask Contact, France

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Duke University Medical Center

Durham, United States, 27710

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Indiana University Hospital

Indianapolis, United States, 46202

Locations

Barnes-Jewish Hospital

St. Louis, United States, 63110-1094

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University of Utah

Salt Lake City, United States, 84108

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Bayer Clinical Research Center

ask Contact, Austria

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Bayer Clinical Research Center

ask Contact, Canada

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Bayer Clinical Research Center

ask Contact, Germany

Locations

Bayer Clinical Research Center

ask Contact, Denmark

Locations

Bayer Clinical Research Center

ask Contact, United Kingdom

Trial Design