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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Blood Loss, Surgical, Postoperative Hemorrhage

Thank you

Trial Information

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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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)

Outcome Time Frame:

Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

12002

NCT ID:

NCT00306150

Start Date:

December 2005

Completion Date:

March 2007

Related Keywords:

  • Blood Loss, Surgical
  • Postoperative Hemorrhage
  • Prevention of blood loss
  • Blood Loss, Surgical
  • Blood Loss, Postoperative
  • Hemorrhage
  • Postoperative Hemorrhage
  • Blood Loss, Surgical

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Fountain Valley, California  92708
Miami, Florida  33176
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Flint, Michigan  48532
Scarborough, Maine  04074
Denver, Colorado  
Baltimore, Maryland  21287
Charlotte, North Carolina  
South Burlington, Vermont  
Tulsa, Oklahoma