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

Blood Loss, Surgical Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00327379
• Other study ID #: 11799
• Secondary ID: 2005-003999-38
• Status: Terminated
• Phase: Phase 3
• Start date: February 27, 2006
• Est. completion date: March 1, 2007

Study information

• Verified date: June 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: March 1, 2007
• Est. primary completion date: March 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Trasylol (Aprotinin, BAYA0128)
Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
• Placebo
Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Canada,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic)		anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge).
Secondary	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		surgery to discharge
Secondary	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		surgery to discharge
Secondary	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		surgery to discharge
Secondary	The number of units of blood or packed red cells transfused per patient requiring transfusion		surgery to discharge
Secondary	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)		surgery to discharge
Secondary	Blood loss during surgery, based on qualitative and quantitative estimates		surgery
Secondary	The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).		pre-op and day 3 post surgery
Secondary	Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures		surgery to discharge
Secondary	The percent of patients receiving colloid or other blood products, and the number of units transfused		surgery to discharge
Secondary	Changes in blood markers related to inflammation and blood coagulation		surgery to discharge
Secondary	Changes in FEV1		surgery to discharge

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