Deep Vein ThrombosisNCT01007045
Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis
An observational study of Deep Vein Thrombosis, run by Queen's University at 2 sites in Canada.
Trial summary
Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- How many people
- 227 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2009to Jun 2011
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: emergency patients suspected of deep vein thrombosis
Who may be able to join
- Age > 16 years
- Clinically suspected lower extremity DVT
Who cannot join
- Known chronic DVT
- Acute DVT confirmed by prior formal imaging
- Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.)
- Anticoagulation >48 hours prior to imaging (formal or LCU)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
About this study
Official title: Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?
Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound.
The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.
- Conditions
- Deep Vein Thrombosis
- Keywords
- deep vein thrombosis, venous thromboembolic disorders, diagnostic ultrasound
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinically "likely" | Subjects deemed clinically likely to have DVT based on modified Well's criteria | |
| Clinically "unlikely" | Subjects deemed clinically unlikely to have DVT based on modified Well's criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
Measured: 3 days
Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients.
Measured: 3 days
Secondary outcomes (5)
interobserver reliability of modified Well's criteria
Measured: 3 days
learning curve for LC U/S by emergency physicians and residents
Measured: 365 days
difference in diagnostic time interval for patients grouped by pre-test probability
Measured: 3 days
number of return visits for formal ultrasound imaging
Measured: 3 days
number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep 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
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Rachel Poley, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007045
- Sponsor's protocol ID
- EMED-123-09
- Status last verified
- Jun 2011
- First submitted
- 2 Nov 2009
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Poley RA, Newbigging JL, Sivilotti ML. Estimated effect of an integrated approach to suspected deep venous thrombosis using limited-compression ultrasound. Acad Emerg Med. 2014 Sep;21(9):971-80. doi: 10.1111/acem.12459.
PubMed 25269577
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?
- ClinicalTrials.gov ID
- NCT01007045
- Acronym / sponsor ID
- EMED-123-09
- Conditions
- Deep Vein Thrombosis
- Keywords
- deep vein thrombosis, venous thromboembolic disorders, diagnostic ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Nov 2009 (estimated)
- 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.
Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound.
The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinically "likely" | – | –Subjects deemed clinically likely to have DVT based on modified Well's criteria |
| Clinically "unlikely" | – | –Subjects deemed clinically unlikely to have DVT based on modified Well's criteria |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- emergency patients suspected of deep vein thrombosis
Key inclusion criteria (2 listed)
- Age > 16 years
- Clinically suspected lower extremity DVT
Key exclusion criteria (4 listed)
- Known chronic DVT
- Acute DVT confirmed by prior formal imaging
- Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.)
- Anticoagulation >48 hours prior to imaging (formal or LCU)
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
First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients.
Time frame: 3 days
Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically "likely" DVT patients.
Time frame: 3 days
5 secondary outcomes
interobserver reliability of modified Well's criteria
Time frame: 3 days
learning curve for LC U/S by emergency physicians and residents
Time frame: 365 days
difference in diagnostic time interval for patients grouped by pre-test probability
Time frame: 3 days
number of return visits for formal ultrasound imaging
Time frame: 3 days
number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending
Time frame: 3 days
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 9 Jun 2011.
- Derived from this study: PubMed 25269577Poley RA, Newbigging JL, Sivilotti ML. Estimated effect of an integrated approach to suspected deep venous thrombosis using limited-compression ultrasound. Acad Emerg Med. 2014 Sep;21(9):971-80. doi: 10.1111/acem.12459.
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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.
Rachel Poley, MD principal investigator
Queen's University
2 sites 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, run by Queen's University at 2 sites 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 2 inclusion and 4 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 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically "unlikely" DVT patients. (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007045, which also lists 1 linked publication.
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 9 Jun 2011.