Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

NCT01324037 | Completed

• 1 other identifier: NL29834.018.09
• Study Type: interventional
• Target: 406
• Locations: 7 countries
• Sites: 18

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.

Conditions

Suspected Upper Extremity Deep Vein Thrombosis

Keywords

suspected upper extremity deep vein thrombosis; diagnostic algorithm

Outcome Measures

Primary Outcomes (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.

  3 months

Study Arms (1)

clinically suspected upper extremity deep vein thrombosis

EXPERIMENTAL

Patients with suspected upper extremity DVT

Other: diagnostic algorithm

Interventions

diagnostic algorithm OTHER

diagnostic algorithm consisting of a clinical decision rule, D-dimer and (serial) ultrasonography

clinically suspected upper extremity deep vein thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from the emergency department, in and out patient clinic with clinically suspected upper extremity deep vein thrombosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (18)

Veterans Affairs Hospital

Washington D.C., District of Columbia, 20420, United States

Location

Medical University Graz

Graz, Austria

Location

Medical University Innsbruck

Innsbruck, Austria

Location

University Hospital Leuven

Leuven, Belgium

Location

University Hospital Dresden

Dresden, Germany

Location

Ospedali Riuniti

Bergamo, Italy

Location

University Hospital Bologna

Bologna, Italy

Location

Hospital D'Annunziata

Chieti, Italy

Location

University Hospital of Padova

Padua, Italy

Location

Servizio Sanitario Regionale Emilia - Romagna

Reggio Emilia, Italy

Location

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Slotervaart Hospital

Amsterdam, Netherlands

Location

Maxima Medisch Centrum

Eindhoven/Veldhoven, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Academic Hospital Maastricht

Maastricht, Netherlands

Location

Antonius Hospital

Nieuwegein, Netherlands

Location

Geneva University Hospital

Geneva, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 18217155 BACKGROUND

• 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.

  PMID: 17024601 BACKGROUND

• 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.

  PMID: 12069560 BACKGROUND

• 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.

  PMID: 20141579 BACKGROUND

• 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.

  PMID: 24687068 DERIVED

Study Officials

• Pieter Willem Kamphuisen, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: March 28, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DE (1); IT (5); US (1); NL (7); CH (1); BE (1); AU (2)