Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Blood loss
Study Overview
Brief 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%. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •transurethral surgery
Exclusion Criteria
- •oral anticoagulation
Arms & Interventions
A
5000IE dalteparine
Intervention: dalteparine (Fragmin) (Drug)
B
NaCL 0.9%
Intervention: dalteparine (Fragmin) (Drug)
Outcomes
Primary Outcomes
Blood loss
Time Frame: intraoperativ, 6 hours post op and 3 days postop
Secondary Outcomes
No secondary outcomes reported