Back to resultsProspective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate
Primary Purpose
Blood Loss, Surgical, Intraoperative Complications, Re-operation Rates in Patients With Aspirin Treatment
Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
transurethral surgery with or without aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss, Surgical focused on measuring aspirin, blood loss, transurethral surgery
Eligibility Criteria
Inclusion Criteria:
- Transurethral surgery of the bladder or prostate, informed consent, age over 18
Exclusion Criteria:
- Oral anticoagulation,
Sites / Locations
- Urologische Universitätsklinik Basel-Liestal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
aspirin 100mg
empty capsule
Outcomes
Primary Outcome Measures
Blood loss
Secondary Outcome Measures
Reoperation rates
Full Information
NCT ID
NCT00861367
First Posted
March 12, 2009
Last Updated
November 17, 2016
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00861367
Brief Title
Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate
Official Title
Prospektive Doppel-Blind-randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
difficult enrollment, focus of study no longer of interest
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aspirin is very common in older patients. Therefore many of the investigators patients have aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the prostate can be performed with aspirin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Intraoperative Complications, Re-operation Rates in Patients With Aspirin Treatment
Keywords
aspirin, blood loss, transurethral surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
aspirin 100mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
empty capsule
Intervention Type
Drug
Intervention Name(s)
transurethral surgery with or without aspirin
Other Intervention Name(s)
Asprin cardio 100mg
Intervention Description
aspirin 100mg once a day, transurethral surgery with or without aspirin
Primary Outcome Measure Information:
Title
Blood loss
Time Frame
intraoperative, 6 hours post op, 3 days postop
Secondary Outcome Measure Information:
Title
Reoperation rates
Time Frame
during hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Transurethral surgery of the bladder or prostate, informed consent, age over 18
Exclusion Criteria:
Oral anticoagulation,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas C Gasser, Prof
Organizational Affiliation
Department of Urology, Liestal
Official's Role
Study Chair
Facility Information:
Facility Name
Urologische Universitätsklinik Basel-Liestal
City
Liestal
ZIP/Postal Code
4410
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate
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