Superficial Vein Thrombosis Testing in the Emergency Department

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Kerstin de Wit

About this trial

Superficial vein thrombosis (SVT) occurs when blood in a vein directly under the skin clots. SVT causes vein tenderness, pain, and skin discolouration. Over time, the vein hardens into a firm, nontender, easily palpable lump. SVT commonly occurs in the veins of the leg. Each year, 1 per 1000 people over the age of 18 have SVT. SVT is painful but usually gets better within a month. Four in 100 people with SVT develop progressively worse blood clotting involving the deep veins or lungs.

If a deep vein clot in the leg occurs it can cause permanent disability with post-thrombotic syndrome (long-term leg pain and swelling) and reduced quality of life. If a pulmonary embolism occurs it may cause chest pain, breathlessness, pulmonary hypertension, psychological distress, and potentially death. Guidelines tell doctors to use ultrasound scanning to decide whether SVT needs treatment with a blood thinner or not. Blood thinners prevent the clot from worsening.

Many people who have SVT go to the emergency department. Scanning is limited to the daytime so often people have multiple trips to the emergency department for their scan and they spend many hours waiting for a doctor to see them. Our research group developed simple ways to limit the need for scans for other types of blood clots, like blood clots in the lungs or in the deep veins. We use a simple blood test called D-dimer. We believe we may be able to use D-dimer to help limit the need for SVT scanning.

This is an exploratory study to document what happens to patients tested for SVT in the emergency department, and to see if the D-dimer blood test might be useful in reducing scans. Our research group will review the emergency department charts for patients who came to the emergency department with SVT. Our results will tell us whether further studies would be helpful.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥ 18

Tested for superficial vein thrombosis in the emergency department or urgent care centre

Patients tested for SVT at all sites, including arms, legs and torso

Disqualifiers

Patient opted out of research at the participating site

Patient included in the study in the last 90 days

Trial population

Emergency department patient who is tested for superficial vein thrombosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • D-dimer

    Diagnostic test

    D-dimer blood test levels will be extracted from medical records. This is an non-interventional study.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Emergency department patients tested for superficial vein thrombosis1 intervention

Trial outcomes

Primary outcomes

1

Superficial vein thrombosis, deep vein thrombosis and no thrombosis

SVT will be classified as a) situated within 3 cm of the deep vein junction, b) ≥ 5 cm in length and \> 3 cm from the deep vein junction, and c) SVT \< 5 cm in length and \> 3 cm from the deep vein junction. Diagnosis of deep vein thrombosis and the finding of no thrombosis will be reported.

Time frame
During index testing

Secondary outcomes

1

The secondary outcomes will the subsequent development of recurrent SVT, SVT propagation, deep vein thrombosis, pulmonary embolism, or death from pulmonary embolism among patients diagnosed with SVT at the index visit.

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Kerstin de Wit

Lead sponsor

Queen's University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: