Terminated/Withdrawn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

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)

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

Where to participate

Status	Institution	Location
Completed	University of Pittsburgh Medical Center Health System	Pittsburgh, 15213-2592, United States
Completed	University of Virginia Health System	Charlottesville, 22908, United States
Completed	M. D. Anderson Cancer Center - University of Texas	Houston, 77030, United States
Completed	Emory University School of Medicine	Atlanta, 30322, United States
Completed	CorVasc, MDs, PC	Indianapolis, 46260, United States
Completed	Brigham & Women's Hospital	Boston, 02115-6195, United States
Completed	Medical College of Georgia	Augusta, 30912, United States
Completed	University Hospitals Case Medical Center	Cleveland, 44106-2602, United States
Completed	Bayer Clinical Research Center	ask Contact, Australia
Completed	Bayer Clinical Research Center	ask Contact, Belgium
Completed	Bayer Clinical Research Center	ask Contact, Spain
Terminated	Bayer Clinical Research Center	ask Contact, France
Completed	Duke University Medical Center	Durham, 27710, United States
Completed	Indiana University Hospital	Indianapolis, 46202, United States
Completed	Barnes-Jewish Hospital	St. Louis, 63110-1094, United States
Completed	University of Utah	Salt Lake City, 84108, United States
Completed	Bayer Clinical Research Center	ask Contact, Austria
Completed	Bayer Clinical Research Center	ask Contact, Canada
Completed	Bayer Clinical Research Center	ask Contact, Germany
Completed	Bayer Clinical Research Center	ask Contact, Denmark
Terminated	Bayer Clinical Research Center	ask Contact, United Kingdom

Primary Outcome

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)
Safety Issue:
No

Secondary Outcome

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

Additional Information

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