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

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2005-004055-35-DE
• Date of registration: 21/11/2005
• Prospective Registration: Yes
• Primary sponsor: Bayer HealthCare AG
• Public 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
• Scientific 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
• Date of first enrolment: 02/01/2006
• Target sample size: 284
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004055-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium, Germany, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects (men or non-pregnant women) 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Subjects with previous exposure to aprotinin in the last 6 months (if the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during surgery; if no records are available, or if the subject received aprotinin, the subject should be excluded)
• Subjects with known or suspected allergy to aprotinin
• Subjects undergoing laparoscopic resection.
• Patients with symptoms indicative for sepsis or local urinary tract infections that make the patient inelegible for total or radical cystectomy
• Subjects with a creatinine clearance less than 30 mL/min as calculated by the Cockcroft-Gault formula.
• Subjects with a history of bleeding diathesis or known coagulation factor deficiency
• Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject’s ability to complete the study or precludes the subject’s participation in the study
• Subjects who refuse to receive allogenic blood products for religious or other reasons
• Subjects whose preoperative RBC volume is so low that blood will have to be given peri-operatively (Hct or Hgb values <24% or <8 g/dL, respectively)
• Subjects with a history of Deep Vein Thrombosis or Pulmonary Embolism
• Women who are pregnant, breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
• Women of childbearing potential who are not using a reliable method of contraception. Methods of contraception that are considered reliable are intrauterine devices (IUDs), birth control pills, hormonal implants/patches, and barrier contraception when used with spermicidal products. The "Rythm" method is not considered a reliable method of contraception.
• Planned use of other antifibrinolytic agents (e.g., aminocaproic acid (Amicar®) or tranexamic acid (Cyklokapron®)
• Subjects on chronic anticoagulant treatment with Vitamin K antagonists where it cannot be discontinued for the surgical procedure
• Subjects on an investigational drug (i.e. not marketed) in the 30 days prior to screening or during the trial before the 6 week follow-up visit. Subjects involved in trials of marketed cancer therapy medications (including those approved for another indication) or combination with radiotherapy are allowed.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Radical or total cystectomy on patients with bladder cancer
MedDRA version: 8.1 Level: HLT Classification code 10057191 Term: Transfusion related complications

Intervention(s)

Trade Name: Trasylol
Product Name: Trasylol
Product Code: Bay a 0128
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Aprotinin
Other descriptive name: serine protease inhibitor
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 10000-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: Main objective: The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for subsequent blood transfusion in subjects with bladder cancer undergoing to radical or total cystectomy. The undermentioned procedures are allowed and belong to radical and total cystectomy:
1. total cystectomy
2. radical cystectomy procedures = cystectomy plus removal of adjacent tissues: cystoprostatectomy, removal of bladder and anterior vaginal wall, cystectomy plus ovariectomy and or hysterectomy
3. urinary tract reconstructive procedures: incontinent cutaneous diversion (eg ileal conduit, etc), continent cutaneous diversion (eg Indiana pouch, etc), orthotopic diversion (eg neobladder)

Primary end point(s): The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for subsequent blood transfusion in subjects with bladder cancer undergoing to radical or total cystectomy. 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). The primary analysis will be based on all patients undergoing protocol defined surgery that are valid for analysis of intent to treat.

Secondary Objective:

Secondary ID(s)

Bay a 0128/12002