Clinical trial NCT01324037: Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suspected Upper Extremity Deep Vein Thrombosis
Keywords: suspected upper extremity deep vein thrombosis
diagnostic algorithm
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2011-03-28
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The cumulative 3-month incidence of objectively confirmed symptomatic venous thromboembolic events including UEDVT and PE in patients with a normal diagnostic work-up.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington D.C.
country: United States
facility: Veterans Affairs Hospital
state: District of Columbia
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Bologna
country: Italy
facility: University Hospital Bologna
city: Chieti
country: Italy
facility: Hospital D'Annunziata
city: Padova
country: Italy
facility: University Hospital of Padova
city: Reggio Emilia
country: Italy
facility: Servizio Sanitario Regionale Emilia - Romagna
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Amsterdam
country: Netherlands
facility: Slotervaart Hospital
city: Eindhoven/Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
city: Nieuwegein
country: Netherlands
facility: Antonius Hospital
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Pieter Willem Kamphuisen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Constans J, Salmi LR, Sevestre-Pietri MA, Perusat S, Nguon M, Degeilh M, Labarere J, Gattolliat O, Boulon C, Laroche JP, Le Roux P, Pichot O, Quere I, Conri C, Bosson JL. A clinical prediction score for upper extremity deep venous thrombosis. Thromb Haemost. 2008 Jan;99(1):202-7. doi: 10.1160/TH07-08-0485.
citation: Bernardi E, Pesavento R, Prandoni P. Upper extremity deep venous thrombosis. Semin Thromb Hemost. 2006 Oct;32(7):729-36. doi: 10.1055/s-2006-951458.
citation: Baarslag HJ, van Beek EJ, Koopman MM, Reekers JA. Prospective study of color duplex ultrasonography compared with contrast venography in patients suspected of having deep venous thrombosis of the upper extremities. Ann Intern Med. 2002 Jun 18;136(12):865-72. doi: 10.7326/0003-4819-136-12-200206180-00007.
citation: Di Nisio M, Van Sluis GL, Bossuyt PM, Buller HR, Porreca E, Rutjes AW. Accuracy of diagnostic tests for clinically suspected upper extremity deep vein thrombosis: a systematic review. J Thromb Haemost. 2010 Apr;8(4):684-92. doi: 10.1111/j.1538-7836.2010.03771.x. Epub 2010 Feb 6.
citation: Kleinjan A, Di Nisio M, Beyer-Westendorf J, Camporese G, Cosmi B, Ghirarduzzi A, Kamphuisen PW, Otten HM, Porreca E, Aggarwal A, Brodmann M, Guglielmi MD, Iotti M, Kaasjager K, Kamvissi V, Lerede T, Marschang P, Meijer K, Palareti G, Rickles FR, Righini M, Rutjes AW, Tonello C, Verhamme P, Werth S, van Wissen S, Buller HR. Safety and feasibility of a diagnostic algorithm combining clinical probability, d-dimer testing, and ultrasonography for suspected upper extremity deep venous thrombosis: a prospective management study. Ann Intern Med. 2014 Apr 1;160(7):451-7. doi: 10.7326/M13-2056.