Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis
Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Suspected Upper Extremity Deep Vein Thrombosis
Intervention: diagnostic algorithm (Other)
Phase: N/A
Status: Completed
Sponsored by: University Medical Center Groningen Official(s) and/or principal investigator(s): Pieter Willem Kamphuisen, MD, PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.
Clinical Details
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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: The cumulative 3-month incidence of objectively confirmed symptomatic venous thromboembolic events including UEDVT and PE in patients with a normal diagnostic work-up.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
Slotervaart Hospital, Amsterdam, Netherlands
Maxima Medisch Centrum, Eindhoven/Veldhoven, Netherlands
University Medical Center Groningen, Groningen, Netherlands
Academic Hospital Maastricht, Maastricht, Netherlands
Antonius Hospital, Nieuwegein, Netherlands
Geneva University Hospital, Geneva, Switzerland
Veterans Affairs Hospital, Washington D.C., District of Columbia 20420, United States
Rijnstate Hospital, Arnhem, Gelderland, Netherlands
Additional Information
study website
Related publications: 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, Quéré 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. Bernardi E, Pesavento R, Prandoni P. Upper extremity deep venous thrombosis. Semin Thromb Hemost. 2006 Oct;32(7):729-36. Review. 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. Erratum in: Ann Intern Med. 2003 Mar 4;138(5):438. Di Nisio M, Van Sluis GL, Bossuyt PM, Büller 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. Review.
Starting date: March 2010
Last updated: December 2, 2014
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