Clinical trial NCT00327379: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Postoperative Hemorrhage
Keywords: Bloodloss
Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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).

Primary outcomes:
measure: Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic)
timeFrame: anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge).
Secondary outcomes:
measure: 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
timeFrame: surgery to discharge
measure: 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
timeFrame: surgery to discharge
measure: 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
timeFrame: surgery to discharge
measure: The number of units of blood or packed red cells transfused per patient requiring transfusion
timeFrame: surgery to discharge
measure: 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)
timeFrame: surgery to discharge
measure: Blood loss during surgery, based on qualitative and quantitative estimates
timeFrame: surgery
measure: The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).
timeFrame: pre-op and day 3 post surgery
measure: Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures
timeFrame: surgery to discharge
measure: The percent of patients receiving colloid or other blood products, and the number of units transfused
timeFrame: surgery to discharge
measure: Changes in blood markers related to inflammation and blood coagulation
timeFrame: surgery to discharge
measure: Changes in FEV1
timeFrame: surgery to discharge
Other outcomes:
Locations:
city: Oshawa
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Karlsbad
country: Germany
state: Baden-Württemberg
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Neustadt
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: