EUCTR2005-004689-18-DE进行中（未招募）不适用
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 Surgical Procedures for Lung Cancer or Esophageal Cancer - NA
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Bayer Inc.
- 入组人数
- 696
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 protocol specified oncological surgery. Subjects must have histological or cytological confirmation of malignancy in lung or esophagus.
- •Documented, signed, dated informed consent obtained prior to any study specific procedures being performed. For subjects in stratum I, consent discussion must include the likelihood of pneumonectomy.
- •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 previous 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 undergoing laparoscopic resection.
- •Subjects undergoing thoracoscopic resection or simple (single lobe) lobectomy as the planned procedure.
- •Subjects undergoing any palliative operation.
- •Subjects with sepsis.
- •Subjects with mesothelioma.
- •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 will have to be given perioperatively (pre-operative hematocrit or hemoglobin 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) containing hormones, birth control pills, hormonal implants/patches, and barrier contraception when used with spermicidal products. The Rhythm” method is not considered a reliable method of contraception.
- •Use of other antifibrinolytic agents eg, aminocaproic acid or tranexamic acid.
- •Subjects on a chronic anti-coagulant treatment with vitamin K antagonists where it can not be discontinued presurgery 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.
- •Subjects with known drug hypersensitivity, subjects with an allergic diathesis, and subjects who have been treated with aprotinin more than 6 month ago or for whom there is a suspicion of previous treatment with aprotinin, should be included in the study only if the following precautions are undertaken:
- •- The test dose, loading dose, and infusion of aprotinin must only be administered
- •under careful observation and in the manner indicated in Section 4.5.1.
- •- H1 and H2 antagonists must be administered intravenously 15 minutes prior to
- •administration of the 1 mL (10000 KIU) test dose of aprotinin.
研究者
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