Thrombophylaxis in Transurethral Surgery With Dalteparine

Thrombophylaxis in Transurethral Surgery Clinical Trial

Official title:

Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681785
• Other study ID #: 269/05
• Status: Completed
• Phase: N/A
• First received: April 21, 2008
• Last updated: May 19, 2008
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2008
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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%. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• transurethral surgery

Exclusion Criteria:

• oral anticoagulation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thrombophylaxis in Transurethral Surgery

Intervention

Drug:
• dalteparine (Fragmin)
transurethrals surgery with and without dalteparine

Locations

Country	Name	City	State
Switzerland	Urologische Universitätsklinik beider Basel	Liestal

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss		intraoperativ, 6 hours post op and 3 days postop	Yes