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

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

Study Overview

• Status: Terminated
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: Trasylol (Aprotinin, BAYA0128); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • ask Contact, Australia
• Austria
  • ask Contact, Austria
• Belgium
  • ask Contact, Belgium
• Canada
  • ask Contact, Canada
• Denmark
  • ask Contact, Denmark
• France
  • ask Contact, France
• Germany
  • ask Contact, Germany
• Spain
  • ask Contact, Spain
• United Kingdom
  • ask Contact, United Kingdom
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
    • Augusta, Georgia, United States, 30912
  • Indiana
    • Indianapolis, Indiana, United States, 46260
    • Indianapolis, Indiana, United States, 46202
  • Massachusetts
    • Boston, Massachusetts, United States, 02115-6195
  • Missouri
    • St. Louis, Missouri, United States, 63110-1094
  • North Carolina
    • Durham, North Carolina, United States, 27710
  • Ohio
    • Cleveland, Ohio, United States, 44106-2602
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-2592
  • Texas
    • Houston, Texas, United States, 77030
  • Utah
    • Salt Lake City, Utah, United States, 84108
  • Virginia
    • Charlottesville, Virginia, United States, 22908

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here and search for product information provided by EMA

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: March 21, 2006
• First Submitted That Met QC Criteria: March 21, 2006
• First Posted (Estimate): March 23, 2006

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Hemorrhage; Head and Neck Neoplasms; Esophageal Diseases; Intraoperative Complications; Esophageal Neoplasms; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Hemostatics; Coagulants; Trypsin Inhibitors; Aprotinin
• Other Study ID Numbers: 11800; EudraCT: 2005-004689-18