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Simplification of the Diagnosis of Deep Vein Thrombosis

NCT01412242 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2015-01-26

No results posted yet for this study

Summary

Prospective cohort study aimed at simplifying the diagnostic approach to symptomatic patients with the clinical suspicion of deep vein thrombosis (DVT) of the lower extremities. All patients will receive a pre-test clinical probability (PTP) and the determination of D-dimer. Patients with low PTP and negative D-dimer will have the diagnosis ruled out. All other patients will undergo compression ultrasonography (CUS) of the proximal vein system. Patients with negative CUS and either low PTP or negative D-dimer will have the diagnosis ruled out, while those with high PTP and positive D-dimer will undergo extensive ultrasound investigation of the calf vein system. All patients in whom the diagnosis of DVT is ruled out will be followed-up prospectively up to three months for documenting the development of symptomatic thromboembolic events.

Conditions

  • Deep Venous Thrombosis

Interventions

OTHER

Extensive search for isolated calf DVT

Extensive search for isolated calf DVT in patients with negative CUS of the proximal veins who have a high PTP and a positive D-dimer

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Paolo Prandoni, MD, PhD · University of Padua, Italy

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01412242 on ClinicalTrials.gov