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Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

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 prevention trial for Blood Loss, Surgical focused on measuring Bloodloss, Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

Eligibility Criteria

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

Inclusion Criteria: Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces. 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, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin. Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy. Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula. 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. Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values <24% or <8 g/dl, respectively). Subjects who have participated in an investigational drug study within the past 30 days Subjects with a history of deep vein thrombosis or pulmonary embolism. Subjects who are pregnant or breast feeding. Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening. Women of childbearing potential who are not using a reliable method of contraception. Planned use of other antifibrinolytic agents. Subjects on chronic anticoagulant treatment with Vit K antagonists 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 (blood or packed red blood cells, autologous or allogenic)

Secondary Outcome Measures

The percent of patients 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 patients 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
Drainage (in milliliters) from the operative site in the first 8 hours postoperatively, and total drainage until removal of drains or until hospital discharge (whichever is earlier)
Blood loss during surgery, based on qualitative and quantitative estimates
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).
Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures
The percent of patients receiving colloid or other blood products, and the number of units transfused
Changes in blood markers related to inflammation and blood coagulation
Changes in FEV1

Full Information

First Posted
May 16, 2006
Last Updated
June 2, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00327379
Brief Title
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
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 Elective Spinal Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Study Start Date
February 27, 2006 (Actual)
Primary Completion Date
March 1, 2007 (Actual)
Study Completion Date
March 1, 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation

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
Bloodloss, Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (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
Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
Primary Outcome Measure Information:
Title
Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic)
Time Frame
anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge).
Secondary Outcome Measure Information:
Title
The percent of patients 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 patients 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
Drainage (in milliliters) from the operative site in the first 8 hours postoperatively, and total drainage until removal of drains or until hospital discharge (whichever is earlier)
Time Frame
surgery to discharge
Title
Blood loss during surgery, based on qualitative and quantitative estimates
Time Frame
surgery
Title
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).
Time Frame
pre-op and day 3 post surgery
Title
Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures
Time Frame
surgery to discharge
Title
The percent of patients receiving colloid or other blood products, and the number of units transfused
Time Frame
surgery to discharge
Title
Changes in blood markers related to inflammation and blood coagulation
Time Frame
surgery to discharge
Title
Changes in FEV1
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 spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces. 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, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin. Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy. Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula. 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. Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values <24% or <8 g/dl, respectively). Subjects who have participated in an investigational drug study within the past 30 days Subjects with a history of deep vein thrombosis or pulmonary embolism. Subjects who are pregnant or breast feeding. Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening. Women of childbearing potential who are not using a reliable method of contraception. Planned use of other antifibrinolytic agents. Subjects on chronic anticoagulant treatment with Vit K antagonists 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
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
City
Karlsbad
State/Province
Baden-Württemberg
ZIP/Postal Code
76307
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Neustadt
State/Province
Schleswig-Holstein
ZIP/Postal Code
23730
Country
Germany
City
Berlin
ZIP/Postal Code
13086
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

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Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery

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