Elective Spinal Fusion Surgery MedDRA version: 8.1 Level: HLT Classification code 10057191 Term: Transfusion related complications
Conditions
Sponsors
Bayer Pharmaceuticals Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects 18 years of age and older. • Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. Documented, signed, dated informed consent obtained prior to any study specific procedures being performed. Procedures performed within 30 days of screening (including safety labs, electrocardiogram [ECG], chest x-ray, and physical exam) will be allowed to qualify a patient for study entry once the informed consent has been signed. However, laboratory results and ECG analyses used to qualify a patient need to be performed by the central laboratory. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 30 mL/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 pregnancy test at screening. • Women of childbearing potential who are not using a reliable method of contraception. Methods of contraception that are considered reliabel are intrauterine devices (IUDs), birth control pills, hormonal implants/patches, and barrier contraception which is used with spermicidal products. The "Rhythm" method is not considered 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: ;Primary end point(s): The primary criterion for efficacy is the 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). The primary analysis will be based on all patients undergoing elective, protocol-defined surgery that are valid for analysis of intent to treat. | — |
Countries
Germany, Spain
Outcome results
None listed