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

NCT00306150 | Terminated Phase 3

• 2 other identifiers: 120022005-004055-35
• Study Type: interventional
• Target: 57
• Locations: 7 countries
• Sites: 37

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.

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Keywords

Prevention of blood loss; Blood Loss, Surgical; Blood Loss, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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 number of units of blood or packed red cells transfused per patient requiring transfusion

  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

• Transfusion of platelets, colloids, plasma and number of patients requiring these products

  Intra- and postoperative

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Trasylol (Aprotinin, BAYA0128)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Trasylol (Aprotinin, BAYA0128) DRUG

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.

Arm 1

Placebo DRUG

Placebo is used according to the description of Arm 1

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (37)

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Los Angeles, California, 90095, United States

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Denver, Colorado, 80262, United States

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Miami, Florida, 33125, United States

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Chicago, Illinois, 60612, United States

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Chicago, Illinois, 60637, United States

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Portland, Maine, 04102, United States

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Baltimore, Maryland, 21224, United States

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Ann Arbor, Michigan, 48109-0330, United States

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Rochester, Minnesota, 55905, United States

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Chapel Hill, North Carolina, 27599-7065, United States

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Cleveland, Ohio, 44106-2602, United States

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Columbus, Ohio, 43214-1419, United States

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Oklahoma City, Oklahoma, 73104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15213-2592, United States

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Nashville, Tennessee, 37232, United States

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Houston, Texas, 77030, United States

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Burlington, Vermont, 05401-1420, United States

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Nantes, 44035, France

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Nice, 06200, France

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Tübingen, Baden-Wurttemberg, 72076, Germany

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München, Bavaria, 81377, Germany

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Regensburg, Bavaria, 93053, Germany

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Fulda, Hesse, 36043, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Homburg, Saarland, 66421, Germany

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Dresden, Saxony, 01307, Germany

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Maastricht, 6229 HX, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Linköping, 581 85, Sweden

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Lund, 221 85, Sweden

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Stockholm, 171 76, Sweden

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Uppsala, 751 85, Sweden

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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

Related Links

• Click here and search for information of Bayer products for Europe

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Interventions

Aprotinin

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 23, 2006
• Study Start: December 1, 2005
• Study Completion: March 1, 2007
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

BE (2); FR (2); NL (2); US (18); DE (7); SE (4); GB (2)