EUCTR2005-003999-38-ES进行中（未招募）1 期
Ensayo clínico multicéntrico, aleatorizado, doble ciego, paralelo, controlado con placebo, de dos grupos de tratamiento para evalluar la utilidad de Aprotinina en las necesidades transfusionales en pacientes sometidos a cirugía electiva de fusión vertebral.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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 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
排除标准
- •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 impaired renal function (serum creatinine >2.5 mg/dL or 221 micromoles/liter).
- •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 and who are not using a reliable method of contraception.
- •Planned use of other antifibrinolytic agents, e.g., aminocaproic acid (Amicar®) or tranexamic acid (Cyklokapron?).
- •Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices).
研究者
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