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

The reference standard for the diagnosis of upper extremity deep vein
thrombosis (UEDVT) is contrast venography. Unfortunately, venography is
invasive, often difficult to perform and interpret, and it requires the use of
ionizing radiation. The diagnostic work-up of clinically suspected lower
extremity deep vein thrombosis is well established and is based on a combined
strategy involving clinical probability, D-dimer and imaging tests. It remains
unclear whether clinical probability assessment, the D-dimer test,
ultrasonography can be safely used as a diagnostic strategy to detect UEDVT.

To prospectively evaluate the safety and feasibility of a diagnostic strategy
combining clinical probability, D-dimer testing, (serial) ultrasonography in
patients with clinically suspected UEDVT.

A prospective, multicenter, management study. There will be 2 visits; one when
the patient is included and one telephone call after 3 months.
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 at 3 months. All patients with a likely CDR or unlikely CDR
combined with elevated D-dimer levels will undergo ultrasonography. In case of
a negative or indeterminate ultrasonography result and high D-dimer levels,
serial testing will be repeated 3-5 days later or in case of progressive
complaints. Anticoagulants will be withheld in all patients for whom UEDVT will
be excluded by the initial diagnostic work-up.

Not applicable

The diagnostic algorithm used in this study has not been validated yet. This
might result in excluding UEDVT in patients while they actually have UEDVT
(i.e. false negative results). However, an algorithm like this has been used
for years in the diagnostical work-up in patients with suspected deep vein
thrombosis of the leg. Moreover, patients are instructed to be aware of
complaints suggestive for UEDVT or pulmonary embolism.