stop_circleTerminated/Withdrawn

Blood Loss, Surgical

Bayer Identifier:

11800

ClinicalTrials.gov Identifier:

NCT00306137

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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)

Trial summary

Enrollment Goal
104
Trial Dates
December 2005 - March 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15213-2592, United States
Completed
University of Virginia Health SystemCharlottesville, 22908, United States
Completed
M. D. Anderson Cancer Center - University of TexasHouston, 77030, United States
Completed
Emory University School of MedicineAtlanta, 30322, United States
Completed
CorVasc, MDs, PCIndianapolis, 46260, United States
Completed
Brigham & Women's HospitalBoston, 02115-6195, United States
Completed
Medical College of GeorgiaAugusta, 30912, United States
Completed
University Hospitals Case Medical CenterCleveland, 44106-2602, United States
Completed
Bayer Clinical Research Centerask Contact, Australia
Completed
Bayer Clinical Research Centerask Contact, Belgium
Completed
Bayer Clinical Research Centerask Contact, Spain
Terminated
Bayer Clinical Research Centerask Contact, France
Completed
Duke University Medical CenterDurham, 27710, United States
Completed
Indiana University HospitalIndianapolis, 46202, United States
Completed
Barnes-Jewish HospitalSt. Louis, 63110-1094, United States
Completed
University of UtahSalt Lake City, 84108, United States
Completed
Bayer Clinical Research Centerask Contact, Austria
Completed
Bayer Clinical Research Centerask Contact, Canada
Completed
Bayer Clinical Research Centerask Contact, Germany
Completed
Bayer Clinical Research Centerask Contact, Denmark
Terminated
Bayer Clinical Research Centerask Contact, United Kingdom

Primary Outcome

  • Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
    date_rangeTime Frame:
    Up to the end of follow up visit (4 to 8 weeks)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of units of blood or packed red cells transfused
    date_rangeTime Frame:
    Up to the end of follow up visit (4 to 8 weeks)
    enhanced_encryption
    Safety Issue:
    No
  • Number of units transfused per patient
    date_rangeTime Frame:
    Up to the end of follow up visit (4 to 8 weeks)
    enhanced_encryption
    Safety Issue:
    No
  • Intra-operative blood loss
    date_rangeTime Frame:
    Intra-operative
    enhanced_encryption
    Safety Issue:
    No
  • Drainage volume
    date_rangeTime Frame:
    Until removal of drains
    enhanced_encryption
    Safety Issue:
    No
  • Transfusion of platelets, colloids and plasma
    date_rangeTime Frame:
    Up to the end of follow up visit (4 to 8 weeks)
    enhanced_encryption
    Safety Issue:
    No
  • Change from pre-operative to post-operative hemoglobin concentration
    date_rangeTime Frame:
    At day 3 or earlyer prior to transfusion
    enhanced_encryption
    Safety Issue:
    No
  • Surgeon's assessment of obscurement of operative field by bleeding
    date_rangeTime Frame:
    Up to the end of follow up visit (4 to 8 weeks)
    enhanced_encryption
    Safety Issue:
    No
  • Blood markers of inflammation and coagulation
    date_rangeTime Frame:
    Up to the end of follow up visit (4 to 8 weeks)
    enhanced_encryption
    Safety Issue:
    No
  • Time to discontinuation of mechanical ventilation
    date_rangeTime Frame:
    Until removal of mechanical ventilation
    enhanced_encryption
    Safety Issue:
    No
  • Health related quality of life measurements
    date_rangeTime Frame:
    Up to the end of follow up visit (4 to 8 weeks)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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