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Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

Primary Purpose

Blood Loss, Surgical, Postoperative Hemorrhage

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 focused on measuring Prevention of blood loss, Blood Loss, Surgical, Blood Loss, Postoperative

Eligibility Criteria

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

Inclusion Criteria: Subjects 18 years of age and older Subjects requiring elective radical or total cystectomy for bladder cancer Documented, signed, 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 with sepsis or undergoing laparoscopic surgery 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

The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)

Secondary Outcome Measures

The number of units of blood or packed red cells transfused. There will be an analysis for the combination of autologous and allogenic transfusion and for allogenic alone
The number of units of blood or packed red cells transfused per patient requiring transfusion
The intraoperative blood loss determined as follow: a) by surgeon estimate b) summing weight of the blood in gauze and other materials and the suction drainage volume
The drainage volume (in milliliters) from the operative site
Transfusion of platelets, colloids, plasma and number of patients requiring these products
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration
Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures
Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7
Time to discontinuing of mechanical ventilation
Changes in FEV1
Changes in the patients health related quality of life (HRQoL) (at baseline and 6+-2 weeks post surgery) using the Functional Assessment Cancer Therapy for patients with Bladder cancer (FACT-Bl) questionnaire

Full Information

First Posted
March 21, 2006
Last Updated
December 16, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00306150
Brief Title
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
Official Title
A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.
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

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Postoperative Hemorrhage
Keywords
Prevention of blood loss, Blood Loss, Surgical, Blood Loss, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (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 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 maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is used according to the description of Arm 1
Primary Outcome Measure Information:
Title
The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Time Frame
Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Secondary Outcome Measure Information:
Title
The number of units of blood or packed red cells transfused. There will be an analysis for the combination of autologous and allogenic transfusion and for allogenic alone
Time Frame
Intra- and postoperative
Title
The number of units of blood or packed red cells transfused per patient requiring transfusion
Time Frame
Intra- and postoperative
Title
The intraoperative blood loss determined as follow: a) by surgeon estimate b) summing weight of the blood in gauze and other materials and the suction drainage volume
Time Frame
Intraoperative
Title
The drainage volume (in milliliters) from the operative site
Time Frame
In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first
Title
Transfusion of platelets, colloids, plasma and number of patients requiring these products
Time Frame
Intra- and postoperative
Title
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration
Time Frame
Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusion
Title
Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures
Time Frame
Intraoperative
Title
Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7
Time Frame
Several measurements from baseline up to 6 weeks
Title
Time to discontinuing of mechanical ventilation
Time Frame
Not specifed
Title
Changes in FEV1
Time Frame
Baseline until Discharge or day7
Title
Changes in the patients health related quality of life (HRQoL) (at baseline and 6+-2 weeks post surgery) using the Functional Assessment Cancer Therapy for patients with Bladder cancer (FACT-Bl) questionnaire
Time Frame
At baseline and 6+-2 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects 18 years of age and older Subjects requiring elective radical or total cystectomy for bladder cancer Documented, signed, 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 with sepsis or undergoing laparoscopic surgery 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
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0330
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7065
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-2602
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-1419
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2592
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1420
Country
United States
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Nantes Cedex
ZIP/Postal Code
44035
Country
France
City
Nice
ZIP/Postal Code
06200
Country
France
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36043
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for information of Bayer products for Europe

Learn more about this trial

Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

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