Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
