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Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis (Armour)

This study has been completed.
Information provided by (Responsible Party):
Pieter W. Kamphuisen, MD PhD, University Medical Centre Groningen Identifier:
First received: March 25, 2011
Last updated: December 2, 2014
Last verified: December 2014
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.

Condition Intervention
Suspected Upper Extremity Deep Vein Thrombosis Other: diagnostic algorithm

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by Pieter W. Kamphuisen, MD PhD, University Medical Centre Groningen:

Primary Outcome Measures:
  • The cumulative 3-month incidence of objectively confirmed symptomatic venous thromboembolic events including UEDVT and PE in patients with a normal diagnostic work-up. [ Time Frame: 3 months ]

Enrollment: 406
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clinically suspected upper extremity deep vein thrombosis
Patients with suspected upper extremity DVT
Other: diagnostic algorithm
diagnostic algorithm consisting of a clinical decision rule, D-dimer and (serial) ultrasonography

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01324037

United States, District of Columbia
Veterans Affairs Hospital
Washington D.C., District of Columbia, United States, 20420
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
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
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
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Pieter Willem Kamphuisen, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pieter W. Kamphuisen, MD PhD, MD PhD, University Medical Centre Groningen Identifier: NCT01324037     History of Changes
Other Study ID Numbers: NL29834.018.09
Study First Received: March 25, 2011
Last Updated: December 2, 2014

Keywords provided by Pieter W. Kamphuisen, MD PhD, University Medical Centre Groningen:
suspected upper extremity deep vein thrombosis
diagnostic algorithm

Additional relevant MeSH terms:
Venous Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017