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Prospective Double-Blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University Hospital, Basel, Switzerland.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00861367
First received: March 12, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Blood Loss,Surgical;
Intraoperative Complications;
Reoperation Rates in Patients With Aspirin Treatment;
 Drug: transurethral surgery with or without aspirin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prospektive Doppel-Blind-Randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen

Resource links provided by NLM:

Drug Information available for: Aspirin
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Blood loss [ Time Frame: intraoperative, 6 hours post op, 3 days postop ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reoperation rates [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 124
Study Start Date: September 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
aspirin 100mg
 Drug: transurethral surgery with or without aspirin
aspirin 100mg once a day, transurethral surgery with or without aspirin
Other Name: Asprin cardio 100mg
Placebo Comparator: 2
empty capsule
 Drug: transurethral surgery with or without aspirin
aspirin 100mg once a day, transurethral surgery with or without aspirin
Other Name: Asprin cardio 100mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Transurethral surgery of the bladder or prostate, informed consent, age over 18

Exclusion Criteria:

  • Oral anticoagulation,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861367

Locations
Switzerland
Urologische Universitätsklinik Basel-Liestal
Liestal, Switzerland, 4410
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Chair: thomas C Gasser, Prof Department of Urology, Liestal
  More Information

No publications provided

Responsible Party: Maurer Patrick/Dr., Department of Urology, Kantonsspital Liestal
ClinicalTrials.gov Identifier: NCT00861367     History of Changes
Other Study ID Numbers: 05/08
Study First Received: March 12, 2009
Last Updated: March 12, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
aspirin
blood loss
transurethral surgery

Additional relevant MeSH terms:
Hemorrhage
Intraoperative Complications
Blood Loss, Surgical
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
 Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013