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

December 2, 2014 updated by: Pieter W. Kamphuisen, MD PhD, University Medical Center Groningen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

406

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medical University Graz
      • Innsbruck, Austria
        • Medical University Innsbruck
  • Belgium
      • Leuven, Belgium
        • University Hospital Leuven
  • Germany
      • Dresden, Germany
        • University Hospital Dresden
  • Italy
      • Bergamo, Italy
        • Ospedali Riuniti
      • Bologna, Italy
        • University Hospital Bologna
      • Chieti, Italy
        • Hospital D'Annunziata
      • Padova, Italy
        • University Hospital of Padova
      • Reggio Emilia, Italy
        • Servizio Sanitario Regionale Emilia - Romagna
  • Netherlands
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands
        • Slotervaart Hospital
      • Eindhoven/Veldhoven, Netherlands
        • Maxima Medisch Centrum
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Maastricht, Netherlands
        • Academic Hospital Maastricht
      • Nieuwegein, Netherlands
        • Antonius hospital
    • Gelderland
      • Arnhem, Gelderland, Netherlands
        • Rijnstate Hospital
  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hospital
  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20420
        • Veterans Affairs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Pieter Willem Kamphuisen, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 25, 2011

First Posted (Estimate)

March 28, 2011

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL29834.018.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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