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

This study has been terminated.
Information provided by:
Bayer Identifier:
First received: March 21, 2006
Last updated: December 8, 2014
Last verified: December 2014
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.

Condition Intervention Phase
Blood Loss, Surgical
Drug: Trasylol (Aprotinin, BAYA0128)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]

Secondary Outcome Measures:
  • Number of units of blood or packed red cells transfused [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]
  • Number of units transfused per patient [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]
  • Intra-operative blood loss [ Time Frame: Intra-operative ]
  • Drainage volume [ Time Frame: Until removal of drains ]
  • Transfusion of platelets, colloids and plasma [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]
  • Change from pre-operative to post-operative hemoglobin concentration [ Time Frame: At day 3 or earlyer prior to transfusion ]
  • Surgeon's assessment of obscurement of operative field by bleeding [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]
  • Blood markers of inflammation and coagulation [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]
  • Time to discontinuation of mechanical ventilation [ Time Frame: Until removal of mechanical ventilation ]
  • Health related quality of life measurements [ Time Frame: Up to the end of follow up visit (4 to 8 weeks) ]

Enrollment: 104
Study Start Date: December 2005
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: Arm 1 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
Placebo Comparator: Arm 2 Drug: Placebo
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00306137

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. Identifier: NCT00306137     History of Changes
Other Study ID Numbers: 11800
EudraCT: 2005-004689-18
Study First Received: March 21, 2006
Last Updated: December 8, 2014

Additional relevant MeSH terms:
Esophageal Neoplasms
Blood Loss, Surgical
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes
Intraoperative Complications
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017