Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Hemorrhage

Urinary Bladder Neoplasms

Blood Loss, Surgical

Postoperative Hemorrhage

Intraoperative Complications

Postoperative Complications

Coagulants

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Aprotinin

Hemostatics

Trypsin Inhibitors

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

Subjects 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 maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.

Trasylol (Aprotinin, BAYA0128)

Placebo is used according to the description of Arm 1

Placebo

Bayer Study Director

The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.

Bayer

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Esophageal Neoplasms

Lung Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Pharmaceutical Solutions

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 solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.

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

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

Therapeutic Area Head

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy	NCT00306150	Blood Loss, Sur... Postoperative H...	Trasylol (Aprot... Placebo	18 Years -	Bayer
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer	NCT00306137	Blood Loss, Sur...	Trasylol (Aprot... Placebo	18 Years -	Bayer
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy	NCT00306150	Blood Loss, Sur... Postoperative H...	Trasylol (Aprot... Placebo	18 Years -	Bayer
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer	NCT00306137	Blood Loss, Sur...	Trasylol (Aprot... Placebo	18 Years -	Bayer

Spots Global Cancer Trial Database for trasylol (aprotinin, baya0128)