NCT00306150终止3 期
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.
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
- 57
- 主要终点
- The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
研究概览
简要总结
The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.
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
- Double (Participant, Investigator)
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
- •Subjects 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
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 with sepsis or undergoing laparoscopic surgery
- •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
The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
时间窗: Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
次要结局
- Changes in FEV1(Baseline until Discharge or day7)
- The number of units of blood or packed red cells transfused. There will be an analysis for the combination of autologous and allogenic transfusion and for allogenic alone(Intra- and postoperative)
- The intraoperative blood loss determined as follow: a) by surgeon estimate b) summing weight of the blood in gauze and other materials and the suction drainage volume(Intraoperative)
- The drainage volume (in milliliters) from the operative site(In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first)
- The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration(Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusion)
- Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures(Intraoperative)
- Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7(Several measurements from baseline up to 6 weeks)
- Time to discontinuing of mechanical ventilation(Not specifed)
- Changes in the patients health related quality of life (HRQoL) (at baseline and 6+-2 weeks post surgery) using the Functional Assessment Cancer Therapy for patients with Bladder cancer (FACT-Bl) questionnaire(At baseline and 6+-2 weeks post surgery)
- Transfusion of platelets, colloids, plasma and number of patients requiring these products(Intra- and postoperative)
- The number of units of blood or packed red cells transfused per patient requiring transfusion(Intra- and postoperative)
研究者
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