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Prospective 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Withdrawn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
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical focused on measuring aspirin, blood loss, transurethral surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 12, 2009
Last Updated
November 17, 2016
Sponsor
University Hospital, Basel, Switzerland
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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Withdrawn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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