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

Primary Purpose

Blood Loss, Surgical

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trasylol (Aprotinin, BAYA0128)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss, Surgical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of units of blood or packed red cells transfused
Number of units transfused per patient
Intra-operative blood loss
Drainage volume
Transfusion of platelets, colloids and plasma
Change from pre-operative to post-operative hemoglobin concentration
Surgeon's assessment of obscurement of operative field by bleeding
Blood markers of inflammation and coagulation
Time to discontinuation of mechanical ventilation
Health related quality of life measurements

Full Information

First Posted
March 21, 2006
Last Updated
December 8, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00306137
Brief Title
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Trasylol (Aprotinin, BAYA0128)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of units of blood or packed red cells transfused
Time Frame
Up to the end of follow up visit (4 to 8 weeks)
Title
Number of units transfused per patient
Time Frame
Up to the end of follow up visit (4 to 8 weeks)
Title
Intra-operative blood loss
Time Frame
Intra-operative
Title
Drainage volume
Time Frame
Until removal of drains
Title
Transfusion of platelets, colloids and plasma
Time Frame
Up to the end of follow up visit (4 to 8 weeks)
Title
Change from pre-operative to post-operative hemoglobin concentration
Time Frame
At day 3 or earlyer prior to transfusion
Title
Surgeon's assessment of obscurement of operative field by bleeding
Time Frame
Up to the end of follow up visit (4 to 8 weeks)
Title
Blood markers of inflammation and coagulation
Time Frame
Up to the end of follow up visit (4 to 8 weeks)
Title
Time to discontinuation of mechanical ventilation
Time Frame
Until removal of mechanical ventilation
Title
Health related quality of life measurements
Time Frame
Up to the end of follow up visit (4 to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6195
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1094
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-2602
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2592
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
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Country
Australia
City
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Country
Austria
City
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Country
Belgium
City
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Country
Canada
City
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Country
Denmark
City
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Country
France
City
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Germany
City
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Spain
City
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Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu
Description
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Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer

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