Diagnostic Approach of Deep Vein Thrombosis in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01595763
First received: May 7, 2012
Last updated: May 8, 2012
Last verified: April 2011
  Purpose

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 Intervention
Thrombosis
Other: D Dimer and ultrasonography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Orientación Diagnóstica de la Trombosis Venosa Profunda en la Atención Primaria. Estudio de Coste Efectividad

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Biospecimen Retention:   Samples Without DNA

blood to calculate the value of Dimer D


Estimated Enrollment: 20
Study Start Date: November 2011
Groups/Cohorts Assigned Interventions
Deep Vein Thromobosis signs or symptoms Other: D Dimer and ultrasonography
clinical history, Dimer D, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595763

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

Locations
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

No publications provided

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT01595763     History of Changes
Other Study ID Numbers: IIBSP-TVP-2011-13
Study First Received: May 7, 2012
Last Updated: May 8, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

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:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014