NCT00306137终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 104
- 主要终点
- Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
研究概览
简要总结
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18 years of age and older
- •Subjects requiring protocol specified oncological surgery. Subjects must have histological confirmation of malignancy in lung or esophagus
- •Documented, signed and dated informed consent obtained prior to any study specific procedures being performed
排除标准
- •Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
- •Subjects undergoing laparoscopic surgery
- •Subjects with sepsis or mesothelioma
- •Subjects with impaired renal function (serum creatinine >2.5 mg/dL or 221 micromoles/liter)
- •Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have.
- •Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of <24% or hemoglobin of <8 g/dl)
- •Subjects who have participated in an investigational drug study within the past 30 days
- •Subjects who are pregnant or breastfeeding or 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 or tranexamic acid
- •Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Trasylol (Aprotinin, BAYA0128) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
时间窗: Up to the end of follow up visit (4 to 8 weeks)
次要结局
- Number of units transfused per patient(Up to the end of follow up visit (4 to 8 weeks))
- Drainage volume(Until removal of drains)
- Number of units of blood or packed red cells transfused(Up to the end of follow up visit (4 to 8 weeks))
- Intra-operative blood loss(Intra-operative)
- Transfusion of platelets, colloids and plasma(Up to the end of follow up visit (4 to 8 weeks))
- Change from pre-operative to post-operative hemoglobin concentration(At day 3 or earlyer prior to transfusion)
- Surgeon's assessment of obscurement of operative field by bleeding(Up to the end of follow up visit (4 to 8 weeks))
- Blood markers of inflammation and coagulation(Up to the end of follow up visit (4 to 8 weeks))
- Time to discontinuation of mechanical ventilation(Until removal of mechanical ventilation)
- Health related quality of life measurements(Up to the end of follow up visit (4 to 8 weeks))
研究者
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