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

Phase 3

Terminated

• Conditions: Blood Loss, Surgical; Postoperative Hemorrhage
• Interventions: Drug: Placebo; Drug: Trasylol (Aprotinin, BAYA0128)

• Registration Number: NCT00306150
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-23
• Study Completion: 2007-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Placebo	-
Arm 1	Trasylol (Aprotinin, BAYA0128)	-

Primary Outcome Measures

Name	Time	Method
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)	Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)

Secondary Outcome Measures

Name	Time	Method
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 FEV1	Baseline until Discharge or day7
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