Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

Bayer

Status and phase: Terminated; Phase 3

Conditions: Postoperative Hemorrhage; Blood Loss, Surgical

Treatments: Drug: Placebo; Drug: Trasylol (Aprotinin, BAYA0128)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00306150

2005-004055-35 (EudraCT Number)

12002

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Trasylol (Aprotinin, BAYA0128)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo