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”
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 Type: Interventional
- Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- Study Primary Completion Date: March 2013
Detailed Clinical Trial 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.
Interventions Used in this Clinical Trial
- Other: diagnostic algorithm
- diagnostic algorithm consisting of a clinical decision rule, D-dimer and (serial) ultrasonography
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: clinically suspected upper extremity deep vein thrombosis
- Patients with suspected upper extremity DVT
Outcome Measures for this Clinical Trial
- 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
Safety Issue?: Yes
- Time Frame: 3 months
Criteria for Participation in this Clinical Trial
- Patients from the emergency department, in and out patient clinic with clinically suspected upper extremity deep vein thrombosis
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- University Medical Center Groningen
- Provider of Information About this Clinical Study
- Principal Investigator: Pieter W. Kamphuisen, MD PhD, MD PhD – University Medical Centre Groningen
- Overall Official(s)
- Pieter Willem Kamphuisen, MD, PhD, Principal Investigator, Academisch Medisch Centrum – Universiteit van Amsterdam (AMC-UvA)
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, Quéré 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.
Bernardi E, Pesavento R, Prandoni P. Upper extremity deep venous thrombosis. Semin Thromb Hemost. 2006 Oct;32(7):729-36. Review.
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. Erratum in: Ann Intern Med. 2003 Mar 4;138(5):438.
Di Nisio M, Van Sluis GL, Bossuyt PM, Büller 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. Review.