stop_circleTerminated/Withdrawn

Blood Loss, Surgical, Postoperative Hemorrhage

Bayer Identifier:

12002

ClinicalTrials.gov Identifier:

NCT00306150

EudraCT Number:

2005-004055-35

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

Both

Age

18 Years
  • - 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
  • - 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
57
Trial Dates
December 2005 - March 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum Großhadern der Ludwig-Maximilians-UniversitätMünchen, 81377, Germany
Completed
Klinikum der Johannes-Gutenberg-UniversitätMainz, 55131, Germany
Terminated
Klinikum FuldaFulda, 36043, Germany
Completed
Universitätskliniken des SaarlandesHomburg, 66421, Germany
Terminated
Addenbrookes HospitalCambridge, CB2 0QQ, United Kingdom
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15213-2592, United States
Terminated
Vanderbilt University Medical SchoolNashville, 37232, United States
Terminated
Maine Medical CenterPortland, 04102, United States
Terminated
University of Michigan Health SystemAnn Arbor, 48109-0330, United States
Terminated
Mayo Clinic - RochesterRochester, 55905, United States
Terminated
University of MiamiMiami, 33125, United States
Terminated
University of California, Los AngelesLos Angeles, 90095, United States
Terminated
University Hospitals Case Medical CenterCleveland, 44106-2602, United States
Terminated
University of North CarolinaChapel Hill, 27599-7065, United States
Completed
University of ChicagoChicago, 60637, United States
Terminated
University of Illinois at ChicagoChicago, 60612, United States
Terminated
Hôpital Pasteur - NiceNICE, 06200, France
Terminated
Hôpital Hôtel Dieu - Nantes CedexNANTES CEDEX, 44035, France
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Terminated
Universitair Medisch Centrum St. RadboudNIJMEGEN, 6525 GA, Netherlands
Terminated
Universitetssjukhuset LundLund, 221 85, Sweden
Completed
Klinikum der Universität RegensburgRegensburg, 93053, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Terminated
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Terminated
Freeman HospitalNewcastle Upon Tyne, NE7 7DN, United Kingdom
Terminated
Oklahoma University Health Science CenterOklahoma City, 73104, United States
Completed
Columbus Urology Research, LLCColumbus, 43214-1419, United States
Terminated
M. D. Anderson Cancer Center - University of TexasHouston, 77030, United States
Terminated
Fletcher Allen Health CareBurlington, 05401-1420, United States
Terminated
Johns Hopkins University School of MedicineBaltimore, 21224, United States
Terminated
Thomas Jefferson UniversityPhiladelphia, 19107, United States
Terminated
University of Colorado Health Sciences CenterDenver, 80262, United States
Terminated
Baylor College of MedicineHouston, 77030, United States
Completed
UZ GentGENT, 9000, Belgium
Completed
Academisch Ziekenhuis MaastrichtMAASTRICHT, 6229 HX, Netherlands
Completed
Universitetssjukhuset LinköpingLinköping, 581 85, Sweden
Completed
Akademiska SjukhusetUppsala, 751 85, Sweden
Completed
Karolinska University HospitalStockholm, 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_encryption
    Safety Issue:
    None

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
    date_rangeTime Frame:
    Intra- and postoperative
    enhanced_encryption
    Safety Issue:
    None
  • The number of units of blood or packed red cells transfused per patient requiring transfusion
    date_rangeTime Frame:
    Intra- and postoperative
    enhanced_encryption
    Safety Issue:
    None
  • 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
    date_rangeTime Frame:
    Intraoperative
    enhanced_encryption
    Safety Issue:
    None
  • The drainage volume (in milliliters) from the operative site
    date_rangeTime Frame:
    In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first
    enhanced_encryption
    Safety Issue:
    None
  • Transfusion of platelets, colloids, plasma and number of patients requiring these products
    date_rangeTime Frame:
    Intra- and postoperative
    enhanced_encryption
    Safety Issue:
    None
  • The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration
    date_rangeTime Frame:
    Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusion
    enhanced_encryption
    Safety Issue:
    None
  • Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures
    date_rangeTime Frame:
    Intraoperative
    enhanced_encryption
    Safety Issue:
    None
  • Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7
    date_rangeTime Frame:
    Several measurements from baseline up to 6 weeks
    enhanced_encryption
    Safety Issue:
    None
  • Time to discontinuing of mechanical ventilation
    date_rangeTime Frame:
    Not specifed
    enhanced_encryption
    Safety Issue:
    None
  • Changes in FEV1
    date_rangeTime Frame:
    Baseline until Discharge or day7
    enhanced_encryption
    Safety Issue:
    None
  • 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
    date_rangeTime Frame:
    At baseline and 6+-2 weeks post surgery
    enhanced_encryption
    Safety Issue:
    None

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

Additional Information

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