Thrombophylaxis in Transurethral Surgery With Dalteparine - Full Text View

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00681785

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)

MedlinePlus related topics: Blood Thinners Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Thromboseprophylaxe Mit Niedermolekularem Heparin Bei Transurethralen Eingriffen

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
A: Active Comparator 5000IE dalteparine	Drug: dalteparine (Fragmin) transurethrals surgery with and without dalteparine
B: Placebo Comparator NaCL 0.9%	Drug: dalteparine (Fragmin) transurethrals surgery with and without dalteparine

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

Keywords provided by University Hospital, Basel, Switzerland:

thrombophylaxis and transurethral surgery

Study placed in the following topic categories:

Fibrin Modulating Agents
Anticoagulants
Dalteparin
Fibrinolytic Agents

Cardiovascular Agents
Heparin
Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Dalteparin
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009