Blood Loss, SurgicalNCT00861367
Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate
A study testing transurethral surgery with or without aspirin in people with Blood Loss, Surgical and Intraoperative Complications, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical, Intraoperative Complications, Re-operation Rates in Patients With Aspirin Treatment
- What is being tested?
- transurethral surgery with or without aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transurethral surgery of the bladder or prostate, informed consent, age over 18
Who cannot join
- Oral anticoagulation,
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Urologische Universitätsklinik Basel-Liestal
Liestal, 4410
About this study
Official title: Prospektive Doppel-Blind-randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen
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.
- Conditions
- Blood Loss, Surgical, Intraoperative Complications, Re-operation Rates in Patients With Aspirin Treatment
- Being tested
- transurethral surgery with or without aspirin
- Keywords
- aspirin, blood loss, transurethral surgery
- Medical subject headings
- Blood Loss, Surgical, Intraoperative Complications, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transurethral surgery with or without aspirinDrug
Also called Asprin cardio 100mg
aspirin 100mg once a day, transurethral surgery with or without aspirin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | aspirin 100mg Receives: Drug: transurethral surgery with or without aspirin |
| 2 | Placebo comparator | empty capsule Receives: Drug: transurethral surgery with or without aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Measured: intraoperative, 6 hours post op, 3 days postop
Secondary outcomes (1)
Reoperation rates
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: difficult enrollment, focus of study no longer of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas C Gasser, Prof, Study chair, Department of Urology, Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861367
- Sponsor's protocol ID
- 05/08
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2009
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive Doppel-Blind-randomisierte Studie Zur Verwendung Von Aspirin Bei Transurethralen Operationen
- ClinicalTrials.gov ID
- NCT00861367
- Acronym / sponsor ID
- 05/08
- Conditions
- Blood Loss, Surgical, Intraoperative Complications, Re-operation Rates in Patients With Aspirin Treatment
- Keywords
- aspirin, blood loss, transurethral surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficult enrollment, focus of study no longer of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: transurethral surgery with or without aspirinaspirin 100mg |
| 2 | Placebo comparator | Drug: transurethral surgery with or without aspirinempty capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Transurethral surgery of the bladder or prostate, informed consent, age over 18
Key exclusion criteria (1 listed)
- Oral anticoagulation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transurethral surgery with or without aspirinAlso: Asprin cardio 100mgaspirin 100mg once a day, transurethral surgery with or without aspirin | Drug | 1, 2 |
Primary outcome
Blood loss
Time frame: intraoperative, 6 hours post op, 3 days postop
1 secondary outcome
Reoperation rates
Time frame: during hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Gasser, Prof study chair
Department of Urology, Liestal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transurethral surgery with or without aspirin in people with Blood Loss, Surgical and Intraoperative Complications, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss (time frame: intraoperative, 6 hours post op, 3 days postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.