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Diagnostic Approach of Deep Vein Thrombosis in Primary Care

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ClinicalTrials.gov Identifier: NCT01595763
Recruitment Status : Unknown
Verified April 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : May 10, 2012
Last Update Posted : May 10, 2012
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Thrombosis Other: D Dimer and ultrasonography

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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Orientación Diagnóstica de la Trombosis Venosa Profunda en la Atención Primaria. Estudio de Coste Efectividad
Study Start Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

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


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
blood to calculate the value of Dimer D

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595763


Contacts
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Contact: Eva Fuentes 932082570 31498efc@comb.cat

Locations
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Spain
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Sergi Bellmunt, MD    935537634    sbellmunt@santpau.cat   
Principal Investigator: Eva Fuentes Camps         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01595763    
Other Study ID Numbers: IIBSP-TVP-2011-13
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: April 2011
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Deep vein thrombosis
Primary care
Diagnosis
Clinical model
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fibrin fragment D
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants