Diagnostic Approach of Deep Vein Thrombosis in Primary Care

May 8, 2012 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Orientación Diagnóstica de la Trombosis Venosa Profunda en la Atención Primaria. Estudio de Coste Efectividad

To asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care. To describe the differential diagnosis and the strength of association between each outcome variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional, multicentric study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The participants are the patients referred from the 15 primary care centers (400.000 inhabitants) to the Hospital de la Santa Creu i Sant Pau emergency department with suspected DVT. We will enter physical examination and anamnesis variables, Wells and Oudega's rules variables, D-Dimer value and ultrasonography result. The outcome variables are the cost (€) of each possible way of diagnostic approach and the effectiveness will be measured by the ultrasonography result, which confirms or excludes the diagnosis. The sample will include 437 patients. A decision tree will be developed to analyze the different diagnostic options in DVT cases, using standard notation.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Eva Fuentes Camps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau

Description

Inclusion Criteria:

  • Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau

Exclusion Criteria:

  • anticoagulant treatment
  • patients who will not be able to follow control visit
  • patients with oncologic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Deep Vein Thromobosis signs or symptoms
Other: D Dimer and ultrasonography
clinical history, Dimer D, ultrasonography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Study Registration Dates

First Submitted

May 7, 2012

First Submitted That Met QC Criteria

May 8, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Estimate)

May 10, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TVP-2011-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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