Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

Not Applicable

Completed

• Conditions: Suspected Upper Extremity Deep Vein Thrombosis

• Registration Number: NCT01324037
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Deep vein thrombosis (DVT) of the arm, officially called upper extremity DVT is a rare disorder and accounts for up to 1-4% of all cases of deep vein thrombosis. In case of a thrombosis, there is a blood clot in one of the veins, which should be treated with blood thinners (anticoagulants). The aim of the present study is to see whether it is safe to use a combination of tests for the diagnosis of arm thrombosis. In all patients, we will use a clinical decision rule (clinical judgement) and a laboratory test (D-dimer testing), in most patients also an ultrasound of the arm will be done. The combination of these tests was found to be safe and effective in patients with thrombosis of the legs.

Detailed Description

Consecutive patients with clinically suspected upper extremity deep vein thrombosis (UEDVT) are potentially eligible for the study. Patients will be categorized as likely or unlikely to have UEDVT based on a clinical decision rule (CDR). Patients "unlikely" for UEDVT based on the CDR and with normal D-dimer levels will not receive anticoagulant treatment and will be followed-up for 3 months. All patients with a likely CDR or patients with an unlikely CDR combined with elevated D-dimer levels will undergo ultrasonography. In case of an indeterminate ultrasonography result, ultrasonography testing will be repeated 3-5 days later. The same applies for patients with a negative ultrasound and the combination of a high probability and elevated D-dimer levels. Anticoagulants will be withheld in all patients for whom UEDVT will be excluded by the initial diagnostic work-up.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-25
• Study First Posted: 2011-03-28
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

• Patients from the emergency department, in and out patient clinic with clinically suspected upper extremity deep vein thrombosis

Exclusion Criteria

• No informed consent obtained
• Legal age limitation (country specific)
• Use of anticoagulants in therapeutic dosages longer than 24 hours prior to randomisation
• Prior vein thrombosis in the same arm
• Life expectancy < 3 months
• Haemodynamic instability
• Previous participation in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The cumulative 3-month incidence of objectively confirmed symptomatic venous thromboembolic events including UEDVT and PE in patients with a normal diagnostic work-up.	3 months

Trial Locations

Locations (18)

Veterans Affairs Hospital; 🇺🇸 Washington D.C., District of Columbia, United States

Medical University Graz; 🇦🇹 Graz, Austria

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

University Hospital Leuven; 🇧🇪 Leuven, Belgium

University Hospital Dresden; 🇩🇪 Dresden, Germany

Ospedali Riuniti; 🇮🇹 Bergamo, Italy

University Hospital Bologna; 🇮🇹 Bologna, Italy

Hospital D'Annunziata; 🇮🇹 Chieti, Italy

University Hospital of Padova; 🇮🇹 Padova, Italy

Servizio Sanitario Regionale Emilia - Romagna; 🇮🇹 Reggio Emilia, Italy

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