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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Blood Loss, Surgical

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period

Outcome Time Frame:

Up to the end of follow up visit (4 to 8 weeks)

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

11800

NCT ID:

NCT00306137

Start Date:

December 2005

Completion Date:

March 2007

Related Keywords:

  • Blood Loss, Surgical
  • Esophageal Neoplasms
  • Hemorrhage
  • Blood Loss, Surgical

Name

Location

Albany, Georgia  31701
Columbia, Missouri  65203
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
McLean, Virginia  22101
Boston, Massachusetts  
Charlotte, North Carolina  
Indianapolis, Indiana  
Salt Lake City, Utah  84112