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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00306137 |
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
Condition | Intervention | Phase |
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Blood Loss, Surgical |
Drug: Trasylol (Aprotinin, BAYA0128) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 101 |
Study Start Date: | December 2005 |
Study Completion Date: | March 2007 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: 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:
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Arm 2: Placebo Comparator |
Drug: Placebo
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 11800, EudraCT: 2005-004689-18 |
Study First Received: | March 21, 2006 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00306137 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Serine Proteinase Inhibitors Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Blood Loss, Surgical Esophageal Cancer Hemorrhage Intraoperative Complications Hemostatics |
Protease Inhibitors Aprotinin Digestive System Diseases Lung Neoplasms Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Serine |
Serine Proteinase Inhibitors Digestive System Neoplasms Coagulants Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Esophageal Neoplasms Hematologic Agents Enzyme Inhibitors Blood Loss, Surgical Hemorrhage Intraoperative Complications Hemostatics |
Pharmacologic Actions Protease Inhibitors Aprotinin Neoplasms Neoplasms by Site Digestive System Diseases Pathologic Processes Therapeutic Uses Head and Neck Neoplasms Trypsin Inhibitors Gastrointestinal Neoplasms Esophageal Diseases |