NCT00306137

Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.

Conditions

• Blood Loss, Surgical

Interventions

Type	Name	Description
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: * Stratum 1: complete primary pneumonectomy * Stratum II: decortication or completion pneumonectomy * Stratum III: esophagectomy by transhiatal approach * Stratum IV: esophagectomy by transthoracic approach
DRUG	Placebo	Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.

Timeline

• Start date: 2005-12-01
• Completion: 2007-03-01
• First posted: 2006-03-23
• Last updated: 2014-12-09

Locations

21 sites across 10 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Spain, United Kingdom