Thrombophylaxis in Transurethral SurgeryNCT00681785
Thrombophylaxis in Transurethral Surgery With Dalteparine
A study testing dalteparine (Fragmin) in people with Thrombophylaxis in Transurethral Surgery, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The rationale for thrombophrophylaxis is well known. Without prophylaxis the incidence of objectivlely confirmed, hospital-acquired deep venous thrombosis is approximately 10% to 40% among medical or general surgical patients. In urology the prevalence is 15-40%. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombophylaxis in Transurethral Surgery
- What is being tested?
- dalteparine (Fragmin)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2006to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- transurethral surgery
Who cannot join
- oral anticoagulation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Urologische Universitätsklinik beider Basel
Liestal, 4410
About this study
Official title: Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen
The rationale for thrombophrophylaxis is well known. Without prophylaxis the incidence of objectivlely confirmed, hospital-acquired deep venous thrombosis is approximately 10% to 40% among medical or general surgical patients. In urology the prevalence is 15-40%. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy1 recommend against specific prophylaxis in patients undergoing transurethral procedures. Our study is the first double-blind, placebo-controlled study with Dalteparine as thrombophrophylaxis in transurethral surgery. The aim of the study is to proof that thrombophrophylaxis causes not more complications in transurethral surgery than without.
Read the detailed description
The aim of our study is to proof that transurethral surgery under thrombophylaxis with dalteparine is safe. The study design is double-blind placebo controlled.
- Conditions
- Thrombophylaxis in Transurethral Surgery
- Being tested
- dalteparine (Fragmin)
- Keywords
- thrombophylaxis and transurethral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalteparine (Fragmin)Drug
Also called Dlateparine=Fragmin
transurethrals surgery with and without dalteparine
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 5000IE dalteparine Receives: Drug: dalteparine (Fragmin) |
| B | Placebo comparator | NaCL 0.9% Receives: Drug: dalteparine (Fragmin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Measured: intraoperativ, 6 hours post op and 3 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombophylaxis in Transurethral SurgeryStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Thomas C Gasser, Prof, Study chair, Department of Urology Liestal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681785
- Sponsor's protocol ID
- 269/05
- Status last verified
- May 2008
- First submitted
- 21 Apr 2008
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen
- ClinicalTrials.gov ID
- NCT00681785
- Acronym / sponsor ID
- 269/05
- Conditions
- Thrombophylaxis in Transurethral Surgery
- Keywords
- thrombophylaxis and transurethral surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 21 May 2008 (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.
The rationale for thrombophrophylaxis is well known. Without prophylaxis the incidence of objectivlely confirmed, hospital-acquired deep venous thrombosis is approximately 10% to 40% among medical or general surgical patients. In urology the prevalence is 15-40%. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy1 recommend against specific prophylaxis in patients undergoing transurethral procedures. Our study is the first double-blind, placebo-controlled study with Dalteparine as thrombophrophylaxis in transurethral surgery. The aim of the study is to proof that thrombophrophylaxis causes not more complications in transurethral surgery than without.
Detailed description
The aim of our study is to proof that transurethral surgery under thrombophylaxis with dalteparine is safe. The study design is double-blind placebo controlled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: dalteparine (Fragmin)5000IE dalteparine |
| B | Placebo comparator | Drug: dalteparine (Fragmin)NaCL 0.9% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- transurethral surgery
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 |
|---|---|---|
| dalteparine (Fragmin)Also: Dlateparine=Fragmintransurethrals surgery with and without dalteparine | Drug | A, B |
Primary outcome
Blood loss
Time frame: intraoperativ, 6 hours post op and 3 days postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2008.
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 dalteparine (Fragmin) in people with Thrombophylaxis in Transurethral Surgery, 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: finished, as of the sponsor's last update on 21 May 2008. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: intraoperativ, 6 hours post op and 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 21 May 2008; AzTrials last refreshed its copy on 6 Nov 2026.