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Thrombophylaxis in Transurethral Surgery With Dalteparine

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00681785
First received: April 21, 2008
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention
Thrombophylaxis in Transurethral Surgery
 Drug: dalteparine (Fragmin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Blood loss [ Time Frame: intraoperativ, 6 hours post op and 3 days postop ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
5000IE dalteparine
 Drug: dalteparine (Fragmin)
transurethrals surgery with and without dalteparine
Other Name: Dlateparine=Fragmin
Placebo Comparator: B
NaCL 0.9%
 Drug: dalteparine (Fragmin)
transurethrals surgery with and without dalteparine
Other Name: Dlateparine=Fragmin

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • transurethral surgery

Exclusion Criteria:

  • oral anticoagulation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681785

Locations
Switzerland
Urologische Universitätsklinik beider Basel
Liestal, Switzerland, 4410
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Chair: Thomas C Gasser, Prof Department of Urology Liestal
  More Information

No publications provided

Responsible Party: Maurer Patrick, Dr, Department of Urology, Kantonsspital Liestal
ClinicalTrials.gov Identifier: NCT00681785     History of Changes
Other Study ID Numbers: 269/05
Study First Received: April 21, 2008
Last Updated: May 19, 2008
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
thrombophylaxis and transurethral surgery

Additional relevant MeSH terms:
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013