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

Primary Purpose

Suspected Upper Extremity Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
diagnostic algorithm
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Suspected Upper Extremity Deep Vein Thrombosis focused on measuring suspected upper extremity deep vein thrombosis, diagnostic algorithm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Hospital
  • Medical University Graz
  • Medical University Innsbruck
  • University Hospital Leuven
  • University Hospital Dresden
  • Ospedali Riuniti
  • University Hospital Bologna
  • Hospital D'Annunziata
  • University Hospital of Padova
  • Servizio Sanitario Regionale Emilia - Romagna
  • Rijnstate Hospital
  • Onze Lieve Vrouwe Gasthuis
  • Slotervaart Hospital
  • Maxima Medisch Centrum
  • University Medical Center Groningen
  • Academic Hospital Maastricht
  • Antonius Hospital
  • Geneva University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clinically suspected upper extremity deep vein thrombosis

Arm Description

Patients with suspected upper extremity DVT

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2011
Last Updated
December 2, 2014
Sponsor
University Medical Center Groningen
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1. Study Identification

Unique Protocol Identification Number
NCT01324037
Brief Title
Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis
Acronym
Armour
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Upper Extremity Deep Vein Thrombosis
Keywords
suspected upper extremity deep vein thrombosis, diagnostic algorithm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clinically suspected upper extremity deep vein thrombosis
Arm Type
Experimental
Arm Description
Patients with suspected upper extremity DVT
Intervention Type
Other
Intervention Name(s)
diagnostic algorithm
Intervention Description
diagnostic algorithm consisting of a clinical decision rule, D-dimer and (serial) ultrasonography
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pieter Willem Kamphuisen, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Hospital
City
Washington D.C.
State/Province
District of Columbia
ZIP/Postal Code
20420
Country
United States
Facility Name
Medical University Graz
City
Graz
Country
Austria
Facility Name
Medical University Innsbruck
City
Innsbruck
Country
Austria
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Facility Name
University Hospital Dresden
City
Dresden
Country
Germany
Facility Name
Ospedali Riuniti
City
Bergamo
Country
Italy
Facility Name
University Hospital Bologna
City
Bologna
Country
Italy
Facility Name
Hospital D'Annunziata
City
Chieti
Country
Italy
Facility Name
University Hospital of Padova
City
Padova
Country
Italy
Facility Name
Servizio Sanitario Regionale Emilia - Romagna
City
Reggio Emilia
Country
Italy
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Gelderland
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Slotervaart Hospital
City
Amsterdam
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Eindhoven/Veldhoven
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Academic Hospital Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Geneva University Hospital
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18217155
Citation
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, Quere 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.
Results Reference
background
PubMed Identifier
17024601
Citation
Bernardi E, Pesavento R, Prandoni P. Upper extremity deep venous thrombosis. Semin Thromb Hemost. 2006 Oct;32(7):729-36. doi: 10.1055/s-2006-951458.
Results Reference
background
PubMed Identifier
12069560
Citation
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. doi: 10.7326/0003-4819-136-12-200206180-00007. Erratum In: Ann Intern Med. 2003 Mar 4;138(5):438.
Results Reference
background
PubMed Identifier
20141579
Citation
Di Nisio M, Van Sluis GL, Bossuyt PM, Buller 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.
Results Reference
background
PubMed Identifier
24687068
Citation
Kleinjan A, Di Nisio M, Beyer-Westendorf J, Camporese G, Cosmi B, Ghirarduzzi A, Kamphuisen PW, Otten HM, Porreca E, Aggarwal A, Brodmann M, Guglielmi MD, Iotti M, Kaasjager K, Kamvissi V, Lerede T, Marschang P, Meijer K, Palareti G, Rickles FR, Righini M, Rutjes AW, Tonello C, Verhamme P, Werth S, van Wissen S, Buller HR. Safety and feasibility of a diagnostic algorithm combining clinical probability, d-dimer testing, and ultrasonography for suspected upper extremity deep venous thrombosis: a prospective management study. Ann Intern Med. 2014 Apr 1;160(7):451-7. doi: 10.7326/M13-2056.
Results Reference
derived

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Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

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