Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

NCT ID: NCT01324037

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-04-30

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.

Conditions

Suspected Upper Extremity Deep Vein Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

clinically suspected upper extremity deep vein thrombosis

Patients with suspected upper extremity DVT

Group Type: EXPERIMENTAL

diagnostic algorithm

Intervention Type: OTHER

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

Interventions

diagnostic algorithm

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Pieter W. Kamphuisen, MD PhD

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pieter Willem Kamphuisen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Veterans Affairs Hospital

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

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

Padua, , 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

Countries

United States; Austria; Belgium; Germany; Italy; Netherlands; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 18217155 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17024601 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12069560 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20141579 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24687068 (View on PubMed)

Other Identifiers

NL29834.018.09

Identifier Type: -

Identifier Source: org_study_id