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

Blood Loss, Surgical Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00306150
• Other study ID #: 12002
• Secondary ID: 2005-004055-35
• Status: Terminated
• Phase: Phase 3
• First received: March 21, 2006
• Last updated: December 16, 2014
• Start date: December 2005
• Est. completion date: March 2007

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Trasylol (Aprotinin, BAYA0128)
Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.
• Placebo
Placebo is used according to the description of Arm 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The number of units of blood or packed red cells transfused per patient requiring transfusion		Intra- and postoperative
Secondary	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
Secondary	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
Secondary	Transfusion of platelets, colloids, plasma and number of patients requiring these products		Intra- and postoperative
Secondary	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
Secondary	Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures		Intraoperative
Secondary	Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7		Several measurements from baseline up to 6 weeks
Secondary	Time to discontinuing of mechanical ventilation		Not specifed
Secondary	Changes in FEV1		Baseline until Discharge or day7
Secondary	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

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