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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 alone

The 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

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

click here and search for websynopsis information of Bayer products.

Click here and search for information of Bayer products for Europe

Starting date: December 2005
Last updated: December 16, 2014

Page last updated: August 23, 2015

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