stop_circleTerminated/Withdrawn
Blood Loss, Surgical, Postoperative Hemorrhage
Bayer Identifier:
12002
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
57Trial Dates
December 2005 - March 2007Phase
Phase 3Could I Receive a placebo
YesProducts
Trasylol (Aprotinin, BAYA0128)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum Großhadern der Ludwig-Maximilians-Universität | München, 81377, Germany |
Completed | Klinikum der Johannes-Gutenberg-Universität | Mainz, 55131, Germany |
Terminated | Klinikum Fulda | Fulda, 36043, Germany |
Completed | Universitätskliniken des Saarlandes | Homburg, 66421, Germany |
Terminated | Addenbrookes Hospital | Cambridge, CB2 0QQ, United Kingdom |
Completed | University of Pittsburgh Medical Center Health System | Pittsburgh, 15213-2592, United States |
Terminated | Vanderbilt University Medical School | Nashville, 37232, United States |
Terminated | Maine Medical Center | Portland, 04102, United States |
Terminated | University of Michigan Health System | Ann Arbor, 48109-0330, United States |
Terminated | Mayo Clinic - Rochester | Rochester, 55905, United States |
Terminated | University of Miami | Miami, 33125, United States |
Terminated | University of California, Los Angeles | Los Angeles, 90095, United States |
Terminated | University Hospitals Case Medical Center | Cleveland, 44106-2602, United States |
Terminated | University of North Carolina | Chapel Hill, 27599-7065, United States |
Completed | University of Chicago | Chicago, 60637, United States |
Terminated | University of Illinois at Chicago | Chicago, 60612, United States |
Terminated | Hôpital Pasteur - Nice | NICE, 06200, France |
Terminated | Hôpital Hôtel Dieu - Nantes Cedex | NANTES CEDEX, 44035, France |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Terminated | Universitair Medisch Centrum St. Radboud | NIJMEGEN, 6525 GA, Netherlands |
Terminated | Universitetssjukhuset Lund | Lund, 221 85, Sweden |
Completed | Klinikum der Universität Regensburg | Regensburg, 93053, Germany |
Completed | Medizinische Fakultät Carl Gustav Carus | Dresden, 01307, Germany |
Terminated | Klinikum der Eberhard-Karls-Universität Tübingen | Tübingen, 72076, Germany |
Terminated | Freeman Hospital | Newcastle Upon Tyne, NE7 7DN, United Kingdom |
Terminated | Oklahoma University Health Science Center | Oklahoma City, 73104, United States |
Completed | Columbus Urology Research, LLC | Columbus, 43214-1419, United States |
Terminated | M. D. Anderson Cancer Center - University of Texas | Houston, 77030, United States |
Terminated | Fletcher Allen Health Care | Burlington, 05401-1420, United States |
Terminated | Johns Hopkins University School of Medicine | Baltimore, 21224, United States |
Terminated | Thomas Jefferson University | Philadelphia, 19107, United States |
Terminated | University of Colorado Health Sciences Center | Denver, 80262, United States |
Terminated | Baylor College of Medicine | Houston, 77030, United States |
Completed | UZ Gent | GENT, 9000, Belgium |
Completed | Academisch Ziekenhuis Maastricht | MAASTRICHT, 6229 HX, Netherlands |
Completed | Universitetssjukhuset Linköping | Linköping, 581 85, Sweden |
Completed | Akademiska Sjukhuset | Uppsala, 751 85, Sweden |
Completed | Karolinska University Hospital | Stockholm, 171 76, Sweden |
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)date_rangeTime Frame:Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)enhanced_encryptionNoneSafety Issue:
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 alonedate_rangeTime Frame:Intra- and postoperativeenhanced_encryptionNoneSafety Issue:
- The number of units of blood or packed red cells transfused per patient requiring transfusiondate_rangeTime Frame:Intra- and postoperativeenhanced_encryptionNoneSafety Issue:
- 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 volumedate_rangeTime Frame:Intraoperativeenhanced_encryptionNoneSafety Issue:
- The drainage volume (in milliliters) from the operative sitedate_rangeTime Frame:In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes firstenhanced_encryptionNoneSafety Issue:
- Transfusion of platelets, colloids, plasma and number of patients requiring these productsdate_rangeTime Frame:Intra- and postoperativeenhanced_encryptionNoneSafety Issue:
- The change from preoperative hemoglobin concentration to postoperative hemoglobin concentrationdate_rangeTime Frame:Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusionenhanced_encryptionNoneSafety Issue:
- Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar proceduresdate_rangeTime Frame:Intraoperativeenhanced_encryptionNoneSafety Issue:
- Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7date_rangeTime Frame:Several measurements from baseline up to 6 weeksenhanced_encryptionNoneSafety Issue:
- Time to discontinuing of mechanical ventilationdate_rangeTime Frame:Not specifedenhanced_encryptionNoneSafety Issue:
- Changes in FEV1date_rangeTime Frame:Baseline until Discharge or day7enhanced_encryptionNoneSafety Issue:
- 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) questionnairedate_rangeTime Frame:At baseline and 6+-2 weeks post surgeryenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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