Superficial Vein ThrombosisSVTestNCT07671300
Superficial Vein Thrombosis Testing in the Emergency Department
An observational study of Superficial Vein Thrombosis and D-dimer, run by Dr. Kerstin de Wit at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Vein Thrombosis, D-dimer
- What is being tested?
- D-dimer
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department patient who is tested for superficial vein thrombosis
Who may be able to join
- 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
Who cannot join
- Patient opted out of research at the participating site
- Patient included in the study in the last 90 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
de Wit, MD contact
Canada1 site
Emergency Medicine
Kingston, Ontario, K7L 2V7
Natasha S Clayton, 416-566-3590, natasha.clayton@queensu.ca
About this study
Official title: 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 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.
Read more
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.
- Conditions
- Superficial Vein Thrombosis, D-dimer
- Being tested
- D-dimer
- Keywords
- D-dimer, Superficial vein thrombosis, Emergency Medicine, diagnostic
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-dimerDiagnostic test
D-dimer blood test levels will be extracted from medical records. This is an non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Emergency department patients tested for superficial vein thrombosis | Not described Receives: Diagnostic Test: D-dimer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Vein ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Kerstin de Wit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Kerstin de Wit, Queen's University
- Investigators
- Kerstin de Wit, MD, Principal investigator, Kingston Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671300
- Sponsor's protocol ID
- CTO5894
- Acronym
- SVTest
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Superficial Vein Thrombosis in the Emergency Department.
- ClinicalTrials.gov ID
- NCT07671300
- Acronym / sponsor ID
- SVTest / CTO5894
- Conditions
- Superficial Vein Thrombosis, D-dimer
- Keywords
- D-dimer, Superficial vein thrombosis, Emergency Medicine, diagnostic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Dr. Kerstin de WitUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency department patients tested for superficial vein thrombosis | – | Diagnostic Test: D-dimer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patient who is tested for superficial vein thrombosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient opted out of research at the participating site
- Patient included in the study in the last 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-dimerD-dimer blood test levels will be extracted from medical records. This is an non-interventional study. | Diagnostic test | Emergency department patients tested for superficial vein thrombosis |
Primary outcome
Superficial vein thrombosis, deep vein thrombosis and no thrombosis
Time frame: During index testing
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
de Wit, MD contact
Kerstin de Wit, MD principal investigator
Kingston Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Vein Thrombosis and D-dimer, run by Dr. Kerstin de Wit at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha S Clayton (416-566-3590, natasha.clayton@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial vein thrombosis, deep vein thrombosis and no thrombosis (time frame: During index testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.