EUCTR2005-004055-35-DE进行中（未招募）不适用
A multi-center, randomized, double blind, placebo controlled study to investigate the efficacy and safety of Aprotinin on transfusion requirements in patients with bladder cancer undergoing radical or total cystectomy
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 284
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
- 性别
- All
入选标准
- •Subjects (men or non-pregnant women) 18 years of age and older.
- •Subjects requiring elective radical or total cystectomy for bladder cancer.
- •Documented, signed, dated informed consent obtained prior to any study specific procedures being performed.
- •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 surgery; if no records are available, or if the subject received aprotinin, the subject should be excluded)
- •Subjects with known or suspected allergy to aprotinin
- •Subjects undergoing laparoscopic resection.
- •Patients with symptoms indicative for sepsis or local urinary tract infections that make the patient inelegible for total or radical cystectomy
- •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 RBC volume is so low that blood will have to be given peri-operatively (Hct or Hgb values <24% or <8 g/dL, respectively)
- •Subjects with a history of Deep Vein Thrombosis or Pulmonary Embolism
- •Women who are pregnant, breastfeeding or 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. Methods of contraception that are considered reliable are intrauterine devices (IUDs), birth control pills, hormonal implants/patches, and barrier contraception when used with spermicidal products. The Rythm method is not considered 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 Vitamin K antagonists where it cannot be discontinued for the surgical procedure
- •Subjects on an investigational drug (i.e. not marketed) in the 30 days prior to screening or during the trial before the 6 week follow-up visit. Subjects involved in trials of marketed cancer therapy medications (including those approved for another indication) or combination with radiotherapy are allowed.
研究者
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