Deep Vein Thrombosis (DVT)NCT06195787
Improving Emergency Department Testing for Deep Vein Thrombosis
An observational study of Deep Vein Thrombosis (DVT), run by Dr. Kerstin de Wit at 1 site in Canada.
Trial summary
This observational study will use a new way to test for deep vein thrombosis (DVT) of the leg. A DVT is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. If the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis (DVT)
- How many people
- 458 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Study participants will be enrolled after a visit to the Kingston Health Sciences emergency department and urgent care centre in Kingston, Ontario.
Who may be able to join
- emergency physician decides to test for DVT of the lower limb.
Who cannot join
- <18 years of age;
- tested for DVT without using the ToDay algorithm at the index visit;
- D-dimer level is known before ToDay item assessment;
- a new indication for anticoagulation at the emergency department assessment (other than DVT) in a patient not previously prescribed an anticoagulant;
- a history of prior lower limb DVT, where there is no access to baseline ultrasound imaging;
- suspected of having a pulmonary embolism;
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- has previously participated in this study;
- has previously opted out of all research at hospital site;
- left the emergency department or urgent care centre against medical advice;
- D-dimer was ordered prior to initial physician assessment;
- imaging for DVT or pulmonary embolism within the previous 30 days;
- transferred from another hospital organization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Safety and Efficiency of a Simplified Diagnostic Approach for Deep Vein Thrombosis
This observational study will use a new way to test for deep vein thrombosis (DVT) of the leg. A DVT is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. If the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death.
The main questions the study aims to answer are:
Read more
- How safe is our new blood clot testing method?
- How efficient is our new blood clot testing method?
The study will be run in the emergency department and urgent care centre in Kingston, Ontario. Patients who are tested for a DVT in the leg can be included in the study. Researchers follow the patient through chart review to make sure the new system is safe and efficient.
- Conditions
- Deep Vein Thrombosis (DVT)
- Keywords
- deep vein thrombosis, venous thromboembolism, emergency medical services, diagnosis
- Medical subject headings
- Venous Thrombosis, Venous Thromboembolism, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
False negative rate of the new DVT testing
This is the proportion of patients who have DVT excluded by the new ToDay protocol and who were subsequently diagnosed with either a lower limb DVT or pulmonary embolism.
Measured: This will be measured at 30-days after the patient's index emergency department visit.
Secondary outcomes (1)
Efficiency of the new DVT testing
This is the proportion of all study patients who do not require ultrasound imaging at index visit.
Measured: At the index emergency department visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein Thrombosis (DVT)Studies 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
- Retrospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Kerstin de Wit
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
- Responsible party
- Sponsor-investigator, Dr. Kerstin de Wit, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195787
- Sponsor's protocol ID
- 3717
- Status last verified
- May 2025
- First submitted
- 18 Dec 2023
- Last updated
- 15 May 2025
- 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety and Efficiency of a Simplified Diagnostic Approach for Deep Vein Thrombosis
- ClinicalTrials.gov ID
- NCT06195787
- Acronym / sponsor ID
- 3717
- Conditions
- Deep Vein Thrombosis (DVT)
- Keywords
- deep vein thrombosis, venous thromboembolism, emergency medical services, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Dr. Kerstin de WitUniversity, hospital or other
- Collaborators
- Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 8 Jan 2024 (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.
This observational study will use a new way to test for deep vein thrombosis (DVT) of the leg. A DVT is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. If the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death.
The main questions the study aims to answer are:
- How safe is our new blood clot testing method?
- How efficient is our new blood clot testing method?
The study will be run in the emergency department and urgent care centre in Kingston, Ontario. Patients who are tested for a DVT in the leg can be included in the study. Researchers follow the patient through chart review to make sure the new system is safe and efficient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be enrolled after a visit to the Kingston Health Sciences emergency department and urgent care centre in Kingston, Ontario.
Key inclusion criteria (1 listed)
- emergency physician decides to test for DVT of the lower limb.
Key exclusion criteria (12 listed)
- <18 years of age;
- tested for DVT without using the ToDay algorithm at the index visit;
- D-dimer level is known before ToDay item assessment;
- a new indication for anticoagulation at the emergency department assessment (other than DVT) in a patient not previously prescribed an anticoagulant;
- a history of prior lower limb DVT, where there is no access to baseline ultrasound imaging;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
False negative rate of the new DVT testing
Time frame: This will be measured at 30-days after the patient's index emergency department visit.
This is the proportion of patients who have DVT excluded by the new ToDay protocol and who were subsequently diagnosed with either a lower limb DVT or pulmonary embolism.
1 secondary outcome
Efficiency of the new DVT testing
Time frame: At the index emergency department visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Deep Vein Thrombosis (DVT), 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 1 inclusion and 12 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: finished, as of the sponsor's last update on 15 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False negative rate of the new DVT testing (time frame: This will be measured at 30-days after the patient's index emergency department visit.). 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 15 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.