Back to resultsEffect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
Primary Purpose
Blood Loss, Surgical
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trasylol (Aprotinin, BAYA0128)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss, Surgical focused on measuring Transfusion requirements, Hip replacement surgery, Prevention of blood loss, Bloodloss
Eligibility Criteria
Inclusion Criteria:
- Subjects requiring elective primary total hip replacement surgery
- 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. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, subject should be excluded. If during cardiac surgery in the last 6 months, there is a record of aprotinin administration, subject should be excluded
- Subjects with a known or suspected allergy to aprotinin - Subjects with impaired renal function (serum creatinine > 3.5 mg/dl or 309 micromoles/liter)
- Subjects with a history of bleeding diathesis or known coagulation factor deficiency
- Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Subjects who refuse to receive allogenic blood products for religious or other reasons
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 subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Secondary Outcome Measures
The percent of subjects receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
The percent of subjects who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
The number of units of blood or packed red cells transfused. There will be analyses 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 estimated blood loss during surgery, drainage (in milliliters) from the operative site in the first six hours post-operatively, and total drainage until removal of drains.
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusion
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00668031
Brief Title
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
Keywords
Transfusion requirements, Hip replacement surgery, Prevention of blood loss, Bloodloss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
359 (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
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump
Primary Outcome Measure Information:
Title
Percent of subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Time Frame
intra-op tp discharge
Secondary Outcome Measure Information:
Title
The percent of subjects receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
Time Frame
surgery to discharge
Title
The percent of subjects who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge.
Time Frame
surgery to discharge
Title
The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone.
Time Frame
surgery to discharge
Title
The number of units of blood or packed red cells transfused per patient requiring transfusion.
Time Frame
surgery to discharge
Title
The estimated blood loss during surgery, drainage (in milliliters) from the operative site in the first six hours post-operatively, and total drainage until removal of drains.
Time Frame
surgery to discharge
Title
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusion
Time Frame
pre-operative through day 2
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
surgery
Title
Changes in blood markers related to inflammation and blood coagulation
Time Frame
surgery to discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects requiring elective primary total hip replacement surgery
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. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, subject should be excluded. If during cardiac surgery in the last 6 months, there is a record of aprotinin administration, subject should be excluded
Subjects with a known or suspected allergy to aprotinin - Subjects with impaired renal function (serum creatinine > 3.5 mg/dl or 309 micromoles/liter)
Subjects with a history of bleeding diathesis or known coagulation factor deficiency
Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
Subjects who refuse to receive allogenic blood products for religious or other reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Mooresville
State/Province
Indiana
ZIP/Postal Code
46158
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1089
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
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
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1T2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5N5
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1E 4J4
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2J2
Country
Canada
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 4Z3
Country
Canada
City
Quebec
ZIP/Postal Code
G1L 3L5
Country
Canada
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
12. IPD Sharing Statement
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Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
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