Thrombophylaxis in Transurethral Surgery With Dalteparine

University Hospital Basel

Status: Completed

Conditions: Thrombophylaxis in Transurethral Surgery

Treatments: Drug: dalteparine (Fragmin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00681785

269/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• transurethral surgery

Exclusion criteria

• oral anticoagulation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

5000IE dalteparine

Treatment:

Drug: dalteparine (Fragmin)

B

Placebo Comparator group

Description:

NaCL 0.9%

Treatment:

Drug: dalteparine (Fragmin)