Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00306150
First received: March 21, 2006
Last updated: June 10, 2009
Last verified: June 2009
  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.


Condition Intervention Phase
Blood Loss, Surgical
Postoperative Hemorrhage
Drug: Trasylol (Aprotinin, BAYA0128)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) [ Time Frame: Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge) ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Intra- and postoperative ]
  • The number of units of blood or packed red cells transfused per patient requiring transfusion [ Time Frame: 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 volume [ Time Frame: Intraoperative ]
  • The drainage volume (in milliliters) from the operative site [ Time Frame: 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 products [ Time Frame: Intra- and postoperative ]
  • The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration [ Time Frame: 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 procedures [ Time Frame: Intraoperative ]
  • Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7 [ Time Frame: Several measurements from baseline up to 6 weeks ]
  • Time to discontinuing of mechanical ventilation [ Time Frame: Not specifed ]
  • Changes in FEV1 [ Time Frame: 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) questionnaire [ Time Frame: At baseline and 6+-2 weeks post surgery ]

Enrollment: 278
Study Start Date: December 2005
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: Trasylol (Aprotinin, BAYA0128)
Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.
Placebo Comparator: Arm 2 Drug: Placebo
Placebo is used according to the description of Arm 1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306150

  Show 37 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00306150     History of Changes
Other Study ID Numbers: 12002, EudraCT: 2005-004055-35
Study First Received: March 21, 2006
Last Updated: June 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Prevention of blood loss
Blood Loss, Surgical
Blood Loss, Postoperative

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications
Aprotinin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014