Thrombophylaxis in Transurethral Surgery With Dalteparine
May 19, 2008 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Liestal, Switzerland, 4410
- Urologische Universitätsklinik beider Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- transurethral surgery
Exclusion Criteria:
- oral anticoagulation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: A
5000IE dalteparine
|
transurethrals surgery with and without dalteparine
Other Names:
|
|
PLACEBO_COMPARATOR: B
NaCL 0.9%
|
transurethrals surgery with and without dalteparine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood loss
Time Frame: intraoperativ, 6 hours post op and 3 days postop
|
intraoperativ, 6 hours post op and 3 days postop
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Thomas C Gasser, Prof, Department of Urology Liestal
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
April 21, 2008
First Submitted That Met QC Criteria
May 19, 2008
First Posted (ESTIMATE)
May 21, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 21, 2008
Last Update Submitted That Met QC Criteria
May 19, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 269/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.