Diagnostic Approach of Deep Vein Thrombosis in Primary Care

NCT ID: NCT01595763

Last Updated: 2012-05-10

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

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Deep Vein Thromobosis signs or symptoms

D Dimer and ultrasonography

Intervention Type OTHER

clinical history, Dimer D, ultrasonography

Interventions

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D Dimer and ultrasonography

clinical history, Dimer D, ultrasonography

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Eva Fuentes

Role: CONTACT

932082570

Facility Contacts

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Sergi Bellmunt, MD

Role: primary

935537634

Other Identifiers

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IIBSP-TVP-2011-13

Identifier Type: -

Identifier Source: org_study_id

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