Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
NCT ID: NCT00306137
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
104 participants
INTERVENTIONAL
2005-12-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Trasylol (Aprotinin, BAYA0128)
Subjects successfully meeting all screening criteria will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride.
Subjects will be stratified into one of the 4 following strata:
* Stratum 1: complete primary pneumonectomy
* Stratum II: decortication or completion pneumonectomy
* Stratum III: esophagectomy by transhiatal approach
* Stratum IV: esophagectomy by transthoracic approach
Arm 2
Placebo
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
Interventions
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Trasylol (Aprotinin, BAYA0128)
Subjects successfully meeting all screening criteria will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride.
Subjects will be stratified into one of the 4 following strata:
* Stratum 1: complete primary pneumonectomy
* Stratum II: decortication or completion pneumonectomy
* Stratum III: esophagectomy by transhiatal approach
* Stratum IV: esophagectomy by transthoracic approach
Placebo
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare Pharmaceuticals Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Atlanta, Georgia, United States
Augusta, Georgia, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
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Countries
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Related Links
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Click here and search for product information provided by EMA
Other Identifiers
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EudraCT: 2005-004689-18
Identifier Type: -
Identifier Source: secondary_id
11800
Identifier Type: -
Identifier Source: org_study_id