Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis
- Conditions
- Suspected Upper Extremity Deep Vein Thrombosis
- Interventions
- Other: diagnostic algorithm
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
- Patients from the emergency department, in and out patient clinic with clinically suspected upper extremity deep vein thrombosis
- 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
- Arm && Interventions
Group Intervention Description clinically suspected upper extremity deep vein thrombosis diagnostic algorithm Patients with suspected upper extremity DVT
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Medical University Graz
๐ฆ๐นGraz, Austria
University Hospital Dresden
๐ฉ๐ชDresden, Germany
Medical University Innsbruck
๐ฆ๐นInnsbruck, Austria
Veterans Affairs Hospital
๐บ๐ธWashington D.C., District of Columbia, United States
Ospedali Riuniti
๐ฎ๐นBergamo, Italy
University Hospital Leuven
๐ง๐ชLeuven, Belgium
University Hospital of Padova
๐ฎ๐นPadova, Italy
Hospital D'Annunziata
๐ฎ๐นChieti, Italy
Rijnstate Hospital
๐ณ๐ฑArnhem, Gelderland, Netherlands
Servizio Sanitario Regionale Emilia - Romagna
๐ฎ๐นReggio Emilia, Italy
University Medical Center Groningen
๐ณ๐ฑGroningen, Netherlands
Academic Hospital Maastricht
๐ณ๐ฑMaastricht, Netherlands
Antonius Hospital
๐ณ๐ฑNieuwegein, Netherlands
Geneva University Hospital
๐จ๐ญGeneva, Switzerland
Onze Lieve Vrouwe Gasthuis
๐ณ๐ฑAmsterdam, Netherlands
Slotervaart Hospital
๐ณ๐ฑAmsterdam, Netherlands
Maxima Medisch Centrum
๐ณ๐ฑEindhoven/Veldhoven, Netherlands
University Hospital Bologna
๐ฎ๐นBologna, Italy