Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blood Loss, Surgical; Postoperative Hemorrhage
Intervention: Trasylol (Aprotinin, BAYA0128) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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)
Secondary outcome: 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 aloneThe number of units of blood or packed red cells transfused per patient requiring transfusion 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 The drainage volume (in milliliters) from the operative site Transfusion of platelets, colloids, plasma and number of patients requiring these products The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7 Time to discontinuing of mechanical ventilation Changes in FEV1 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Gent 9000, Belgium
Leuven 3000, Belgium
Nantes Cedex 44035, France
Nice 06200, France
Maastricht 6229 HX, Netherlands
Nijmegen 6525 GA, Netherlands
Linköping 581 85, Sweden
Lund 221 85, Sweden
Stockholm 171 76, Sweden
Uppsala 751 85, Sweden
Tübingen, Baden-Württemberg 72076, Germany
München, Bayern 81377, Germany
Regensburg, Bayern 93053, Germany
Los Angeles, California 90095, United States
Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
Denver, Colorado 80262, United States
Miami, Florida 33125, United States
Fulda, Hessen 36043, Germany
Chicago, Illinois 60612, United States
Chicago, Illinois 60637, United States
Portland, Maine 04102, United States
Baltimore, Maryland 21224, United States
Ann Arbor, Michigan 48109-0330, United States
Rochester, Minnesota 55905, United States
Chapel Hill, North Carolina 27599-7065, United States
Cleveland, Ohio 44106-2602, United States
Columbus, Ohio 43214-1419, United States
Oklahoma City, Oklahoma 73104, United States
Philadelphia, Pennsylvania 19107, United States
Pittsburgh, Pennsylvania 15213-2592, United States
Mainz, Rheinland-Pfalz 55131, Germany
Homburg, Saarland 66421, Germany
Dresden, Sachsen 01307, Germany
Nashville, Tennessee 37232, United States
Houston, Texas 77030, United States
Newcastle Upon Tyne, Tyne and Wear NE7 7DN, United Kingdom
Burlington, Vermont 05401-1420, United States
Additional Information
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Starting date: December 2005
Last updated: December 16, 2014
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