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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
P.W. Kamphuisen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01324037
First received: March 25, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

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 ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324037

Locations
United States, District of Columbia
Veterans Affairs Hospital
Washington D.C., District of Columbia, United States, 20420
Austria
Medical University Graz
Graz, Austria
Medical University Innsbruck
Innsbruck, Austria
Belgium
University Hospital Leuven
Leuven, Belgium
Germany
University Hospital Dresden
Dresden, Germany
Italy
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
Netherlands
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
Switzerland
Geneva University Hospital
Geneva, Switzerland
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Pieter Willem Kamphuisen, MD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Additional Information:
Publications:
Responsible Party: P.W. Kamphuisen, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01324037     History of Changes
Other Study ID Numbers: NL29834.018.09
Study First Received: March 25, 2011
Last Updated: May 24, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission
Austria: Ethikkommission
Belgium: Ethics Committee
Italy: Ethics Committee
United States: Institutional Review Board
Switzerland: Ethikkommission

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
suspected upper extremity deep vein thrombosis
diagnostic algorithm

Additional relevant MeSH terms:
Venous Thrombosis
Thrombosis
Upper Extremity Deep Vein Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014