Trial Condition(s):
Blood Loss, Surgical, Postoperative Hemorrhage
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
Bayer Identifier:
12002
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Klinikum Großhadern der Ludwig-Maximilians-Universität München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johannes-Gutenberg-Universität Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Fulda Fulda, Germany, 36043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätskliniken des Saarlandes Homburg, Germany, 66421 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Addenbrookes Hospital Cambridge, United Kingdom, CB2 0QQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pittsburgh Medical Center Health System Pittsburgh, United States, 15213-2592 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vanderbilt University Medical School Nashville, United States, 37232 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maine Medical Center Portland, United States, 04102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Health System Ann Arbor, United States, 48109-0330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Miami Miami, United States, 33125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, Los Angeles Los Angeles, United States, 90095 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospitals Case Medical Center Cleveland, United States, 44106-2602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of North Carolina Chapel Hill, United States, 27599-7065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Chicago Chicago, United States, 60637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Illinois at Chicago Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Pasteur - Nice NICE, France, 06200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Hôtel Dieu - Nantes Cedex NANTES CEDEX, France, 44035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset Lund Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Universität Regensburg Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Freeman Hospital Newcastle Upon Tyne, United Kingdom, NE7 7DN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oklahoma University Health Science Center Oklahoma City, United States, 73104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbus Urology Research, LLC Columbus, United States, 43214-1419 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations M. D. Anderson Cancer Center - University of Texas Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fletcher Allen Health Care Burlington, United States, 05401-1420 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johns Hopkins University School of Medicine Baltimore, United States, 21224 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thomas Jefferson University Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Colorado Health Sciences Center Denver, United States, 80262 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baylor College of Medicine Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Ziekenhuis Maastricht MAASTRICHT, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset Linköping Linköping, Sweden, 581 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademiska Sjukhuset Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska University Hospital Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
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)Timeframe: 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 aloneTimeframe: Intra- and postoperative
- The number of units of blood or packed red cells transfused per patient requiring transfusionTimeframe: 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 volumeTimeframe: Intraoperative
- The drainage volume (in milliliters) from the operative siteTimeframe: 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 productsTimeframe: Intra- and postoperative
- The change from preoperative hemoglobin concentration to postoperative hemoglobin concentrationTimeframe: 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 proceduresTimeframe: Intraoperative
- Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7Timeframe: Several measurements from baseline up to 6 weeks
- Time to discontinuing of mechanical ventilationTimeframe: Not specifed
- Changes in FEV1Timeframe: 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) questionnaireTimeframe: At baseline and 6+-2 weeks post surgery
Additional Information
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