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CompletedNCT00681785Updated May 21, 2008

Thrombophylaxis in Transurethral Surgery With Dalteparine

An interventional study of dalteparine (Fragmin) in Thrombophylaxis in Transurethral Surgery, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2008-05-21.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thrombophylaxis in Transurethral Surgery

Keywords

  • thrombophylaxis and transurethral surgery
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • transurethral surgery

Exclusion criteria

Exclusion Criteria:

  • oral anticoagulation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
250 participants (actual)

Study arms

  • Active comparator
    A

    5000IE dalteparine

    Drug: dalteparine (Fragmin)

  • Placebo comparator
    B

    NaCL 0.9%

    Drug: dalteparine (Fragmin)

Interventions

  • transurethrals surgery with and without dalteparine

    Also known as: Dlateparine=Fragmin

06

What researchers measure

Primary outcomes

  1. Blood loss

    Time frame: intraoperativ, 6 hours post op and 3 days postop

07

Study locations

1 site
  • Urologische Universitätsklinik beider Basel
    Liestal, 4410, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00681785
First posted
May 21, 2008
Start date
Jun 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
May 21, 2008

Study contacts

Thomas C Gasser, Prof
study chair · Department of Urology Liestal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dalteparin

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