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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

Page last updated: August 20, 2015

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