Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

Study Overview
=================
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.

Official Title
-----------------
Safety and Feasibility of a Diagnostic Algorithm Combining Clinical Probability, D-dimer Test and Ultrasonography in Suspected Upper Extremity Deep Vein Thrombosis: a Prospective Management Study

Conditions
-----------------
Suspected Upper Extremity Deep Vein Thrombosis

Intervention / Treatment
-----------------
* Other: diagnostic algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clinically suspected upper extremity deep vein thrombosis<br>Patients with suspected upper extremity DVT | Other: diagnostic algorithm<br>* diagnostic algorithm consisting of a clinical decision rule, D-dimer and (serial) ultrasonography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suspected upper extremity deep vein thrombosis, diagnostic algorithm