Clinical trial NCT00306150: Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Postoperative Hemorrhage
Keywords: Prevention of blood loss
Blood Loss, Surgical
Blood Loss, Postoperative
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-03-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
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)
timeFrame: Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Secondary outcomes:
measure: 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
timeFrame: Intra- and postoperative
measure: The number of units of blood or packed red cells transfused per patient requiring transfusion
timeFrame: Intra- and postoperative
measure: 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
timeFrame: Intraoperative
measure: The drainage volume (in milliliters) from the operative site
timeFrame: In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first
measure: Transfusion of platelets, colloids, plasma and number of patients requiring these products
timeFrame: Intra- and postoperative
measure: The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration
timeFrame: Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusion
measure: Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures
timeFrame: Intraoperative
measure: Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7
timeFrame: Several measurements from baseline up to 6 weeks
measure: Time to discontinuing of mechanical ventilation
timeFrame: Not specifed
measure: Changes in FEV1
timeFrame: Baseline until Discharge or day7
measure: 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
timeFrame: At baseline and 6+-2 weeks post surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Portland
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Ann Arbor
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Chapel Hill
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Nantes Cedex
country: France
city: Nice
country: France
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Fulda
country: Germany
state: Hessen
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Dresden
country: Germany
state: Sachsen
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Linköping
country: Sweden
city: Lund
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Cambridge
country: United Kingdom
state: Cambridgeshire
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: