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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01324037
Recruitment Status : Completed
First Posted : March 28, 2011
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Pieter W. Kamphuisen, MD PhD, 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.

Condition or disease Intervention/treatment Phase
Suspected Upper Extremity Deep Vein Thrombosis Other: diagnostic algorithm Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
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
Study Start Date : March 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pieter W. Kamphuisen, MD PhD, MD PhD, University Medical Center Groningen Identifier: NCT01324037     History of Changes
Other Study ID Numbers: NL29834.018.09
First Posted: March 28, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Pieter W. Kamphuisen, MD PhD, University Medical Center 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