Clinical trial · Interventional
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
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.
NCT00306150CI-TRIAL-00016364terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Loss, Surgical | — | UNRESOLVED | — |
| Postoperative Hemorrhage | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Trasylol (Aprotinin, BAYA0128) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Trasylol (Aprotinin, BAYA0128)
- type
- PLACEBO_COMPARATOR
- label
- Arm 2
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- 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 (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.