E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elective Spinal Fusion Surgery |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10057191 |
E.1.2 | Term | Transfusion related complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial should last 17 months with LPLV occuring NMT 8 weeks after last treatment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |