Thrombophylaxis in Transurethral Surgery With Dalteparine

Not Applicable

Completed

• Conditions: Thrombophylaxis in Transurethral Surgery
• Interventions: Drug: dalteparine (Fragmin)

• Registration Number: NCT00681785
• Lead Sponsor: University Hospital, Basel, Switzerland

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 Timeline

• Study Start: 2006-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-04-21
• Status Verified: 2008-05
• Study First Submitted QC: 2008-05-19
• Last Update Submitted: 2008-05-19
• Study First Posted: 2008-05-21
• Last Update Posted: 2008-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• transurethral surgery

Exclusion Criteria

• oral anticoagulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	dalteparine (Fragmin)	5000IE dalteparine
B	dalteparine (Fragmin)	NaCL 0.9%

Primary Outcome Measures

Name	Time	Method
Blood loss	intraoperativ, 6 hours post op and 3 days postop

Trial Locations

Locations (1)

Urologische Universitätsklinik beider Basel; 🇨🇭 Liestal, Switzerland