MedDataX Logo

Thrombophylaxis in Transurethral Surgery With Dalteparine

NCT ID: NCT00681785

Last Updated: 2008-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombophylaxis in Transurethral Surgery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

thrombophylaxis and transurethral surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

5000IE dalteparine

Group Type ACTIVE_COMPARATOR

dalteparine (Fragmin)

Intervention Type DRUG

transurethrals surgery with and without dalteparine

B

NaCL 0.9%

Group Type PLACEBO_COMPARATOR

dalteparine (Fragmin)

Intervention Type DRUG

transurethrals surgery with and without dalteparine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dalteparine (Fragmin)

transurethrals surgery with and without dalteparine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dlateparine=Fragmin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* transurethral surgery

Exclusion Criteria

* oral anticoagulation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Urology, Kantonsspital Liestal

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas C Gasser, Prof

Role: STUDY_CHAIR

Department of Urology Liestal

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urologische Universitätsklinik beider Basel

Liestal, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

269/05

Identifier Type: -

Identifier Source: org_study_id