Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

Suspected Upper Extremity Deep Vein Thrombosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324037
• Other study ID #: NL29834.018.09
• Status: Completed
• Phase: N/A
• First received: March 25, 2011
• Last updated: December 2, 2014
• Start date: March 2010
• Est. completion date: April 2013

Study information

• Verified date: December 2014
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Germany: Ethics CommissionAustria: EthikkommissionBelgium: Ethics CommitteeItaly: Ethics CommitteeUnited States: Institutional Review BoardSwitzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Suspected Upper Extremity Deep Vein Thrombosis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	Medical University Innsbruck	Innsbruck
Belgium	University Hospital Leuven	Leuven
Germany	University Hospital Dresden	Dresden
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
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Slotervaart Hospital	Amsterdam
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Maxima Medisch Centrum	Eindhoven/Veldhoven
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Academic Hospital Maastricht	Maastricht
Netherlands	Antonius Hospital	Nieuwegein
Switzerland	Geneva University Hospital	Geneva
United States	Veterans Affairs Hospital	Washington D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Countries where clinical trial is conducted

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

References & Publications (4)

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. — View Citation

Bernardi E, Pesavento R, Prandoni P. Upper extremity deep venous thrombosis. Semin Thromb Hemost. 2006 Oct;32(7):729-36. Review. — View 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, 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   study website