Status:
TERMINATED
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
Lead Sponsor:
Bayer
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00306137
Start Date
December 1 2005
End Date
March 1 2007
Last Update
December 9 2014
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlanta, Georgia, United States, 30322
2
Augusta, Georgia, United States, 30912
3
Indianapolis, Indiana, United States, 46202
4
Indianapolis, Indiana, United States, 46260