Trial Condition(s):
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
11800
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Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
- 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
- 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)
Locations | |
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Locations University of Pittsburgh Medical Center Health System Pittsburgh, United States, 15213-2592 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Virginia Health System Charlottesville, United States, 22908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations M. D. Anderson Cancer Center - University of Texas Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Emory University School of Medicine Atlanta, United States, 30322 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CorVasc, MDs, PC Indianapolis, United States, 46260 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brigham & Women's Hospital Boston, United States, 02115-6195 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical College of Georgia Augusta, United States, 30912 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospitals Case Medical Center Cleveland, United States, 44106-2602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, Australia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, Belgium | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Duke University Medical Center Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Indiana University Hospital Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Barnes-Jewish Hospital St. Louis, United States, 63110-1094 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Utah Salt Lake City, United States, 84108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, Austria | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, Canada | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, Denmark | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bayer Clinical Research Center ask Contact, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2