Diagnostic Approach of Deep Vein Thrombosis in Primary Care

Sponsor

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

Overall Status

Unknown status

CT.gov ID

NCT01595763

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Nov 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Deep Vein Thromobosis signs or symptoms

Other: D Dimer and ultrasonography

clinical history, Dimer D, ultrasonography

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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