- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07671300
Superficial Vein Thrombosis Testing in the Emergency Department (SVTest)
Evaluating Superficial Vein Thrombosis in the Emergency Department.
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 a superficial vein thrombosis (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 causes chest pain, breathlessness, pulmonary hypertension, psychological distress, and potentially death.
Risk factors for SVT include varicose veins, pregnancy, cancer, the use of intravenous catheters, a history of venous thromboembolism, age, and thrombophilia.
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. We 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Natasha S Clayton
- Phone Number: 416-566-3590
- Email: natasha.clayton@queensu.ca
Study Contact Backup
- Name: de Wit, MD
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 2V7
- Emergency Medicine
-
Contact:
- Natasha S Clayton
- Phone Number: 416-566-3590
- Email: natasha.clayton@queensu.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient opted out of research at the participating site
- Patient included in the study in the last 90 days
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Emergency department patients tested for superficial vein thrombosis
|
We will extract data on D-dimer blood test levels.
This is an non-interventional study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Superficial vein thrombosis, deep vein thrombosis and no thrombosis
Time Frame: During index testing
|
We will classify superficial vein thrombosis 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. We will report diagnosis of deep vein thrombosis and the finding of no thrombosis. |
During index testing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kerstin de Wit, MD, Kingston Health Sciences Centre
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTO5894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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