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

This study has been withdrawn prior to enrollment.
(difficult enrollment, focus of study no longer of interest)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00861367
First received: March 12, 2009
Last updated: May 28, 2015
Last verified: May 2015
  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:


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 ]

Enrollment: 0
Study Start Date: September 2008
Study Completion Date: January 2009
Primary Completion Date: January 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00861367     History of Changes
Other Study ID Numbers: 05/08 
Study First Received: March 12, 2009
Last Updated: May 28, 2015
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on September 23, 2016