DEEP VEIN THROMBOSISNCT01045759
Point of Care Ultrasound (US) Versus Detailed Radiology US for Deep Vein Thrombosis (DVT)
An observational study of DEEP VEIN THROMBOSIS, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DEEP VEIN THROMBOSIS
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to May 2015
- 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: The study population will consist of adult patients admitted to the intensive care units at University hospital who have a duplex ultrasound of the lower extremities for detection of deep vein thrombosis ordered by the primary team.
Who may be able to join
- Male and female adults at least 18 years of age
- Duplex ultrasonography ordered by treating team
- Admission to the Medical, Cardiac, Burn, or Surgical intensive care units
Who cannot join
- Patients less than 18 years of age
- Patients with a known current DVT
- patients on whom the exam cannot be performed (above the knee amputation, severe cellulitis of groin or popliteal fossa, hip or knee fracture)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of missouri healthcare
Columbia, Missouri, 65212
About this study
Official title: Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit
We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.
Read the detailed description
Deep vein thrombosis is a common problem in the intensive care unit and diagnosis is often delayed due to limited availability of a formal duplex ultrasound. Physician performed 2 point compression ultrasonography has been shown to have reasonable accuracy when performed in the emergency department and outpatient setting, but has not been studied on patients in the intensive care unit. We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.
- Conditions
- DEEP VEIN THROMBOSIS
- Keywords
- VENOUS THROMBOSIS, ultrasonography, intensive care unit
- Medical subject headings
- Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.
Measured: 48 hours window from detailed US
Secondary outcomes (11)
Subgroup analysis: location of thrombus (proximal or distal)
Measured: 48 hours window from detailed US
Subgroup analysis: number of days in the hospital prior to exam
Measured: 48 hours window from detailed US
Subgroup analysis: body mass index (BMI)
Measured: 48 hours window from detailed US
Subgroup analysis: weight gain from admission to the time of the exam
Measured: 48 hours window from detailed US
Subgroup analysis: training level of examiner
Measured: 48 hours window from detailed US
Subgroup analysis: difficulty of exam
Measured: 48 hours window from detailed US
Subgroup analysis: specific examiner
Measured: 48 hours window from detailed US
Subgroup analysis: presence or absence of calf vein thrombosis
Measured: at study conclusion
Subgroup analysis: presence or absence of pulmonary embolism
Measured: at study conclusion
Subgroup analysis: DVT location
Measured: at study conclusion
Subgroup analysis: calf vein thrombosis
Measured: at study conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DEEP VEIN THROMBOSISStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Casey Stahlheber, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045759
- Sponsor's protocol ID
- 1143800
- Status last verified
- Sep 2016
- First submitted
- 7 Jan 2010
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensivist Performed Limited B Mode Compression Ultrasound for Diagnosis of Deep Vein Thrombosis in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01045759
- Acronym / sponsor ID
- 1143800
- Conditions
- DEEP VEIN THROMBOSIS
- Keywords
- VENOUS THROMBOSIS, ultrasonography, intensive care unit
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left the institution
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Jan 2010 (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.
We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.
Detailed description
Deep vein thrombosis is a common problem in the intensive care unit and diagnosis is often delayed due to limited availability of a formal duplex ultrasound. Physician performed 2 point compression ultrasonography has been shown to have reasonable accuracy when performed in the emergency department and outpatient setting, but has not been studied on patients in the intensive care unit. We propose an observational study to assess the ability of intensivists to evaluate for deep vein thrombosis using 2 point compression ultrasonography.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients admitted to the intensive care units at University hospital who have a duplex ultrasound of the lower extremities for detection of deep vein thrombosis ordered by the primary team.
Key inclusion criteria (3 listed)
- Male and female adults at least 18 years of age
- Duplex ultrasonography ordered by treating team
- Admission to the Medical, Cardiac, Burn, or Surgical intensive care units
Key exclusion criteria (3 listed)
- Patients less than 18 years of age
- Patients with a known current DVT
- patients on whom the exam cannot be performed (above the knee amputation, severe cellulitis of groin or popliteal fossa, hip or knee fracture)
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
The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis.
Time frame: 48 hours window from detailed US
11 secondary outcomes
Subgroup analysis: location of thrombus (proximal or distal)
Time frame: 48 hours window from detailed US
Subgroup analysis: number of days in the hospital prior to exam
Time frame: 48 hours window from detailed US
Subgroup analysis: body mass index (BMI)
Time frame: 48 hours window from detailed US
Subgroup analysis: weight gain from admission to the time of the exam
Time frame: 48 hours window from detailed US
Subgroup analysis: training level of examiner
Time frame: 48 hours window from detailed US
Subgroup analysis: difficulty of exam
Time frame: 48 hours window from detailed US
Subgroup analysis: specific examiner
Time frame: 48 hours window from detailed US
Subgroup analysis: presence or absence of calf vein thrombosis
Time frame: at study conclusion
Subgroup analysis: presence or absence of pulmonary embolism
Time frame: at study conclusion
Subgroup analysis: DVT location
Time frame: at study conclusion
Subgroup analysis: calf vein thrombosis
Time frame: at study conclusion
Results and safety
The study was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- 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.
Casey Stahlheber, MD principal investigator
University of Missouri-Columbia
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, run by University of Missouri-Columbia at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 30 Sep 2016. 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 United States. 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 was stopped early (reason given: Investigator left the institution). Results are not available in the source record.
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?
The agreement between physician performed ultrasound and formal duplex ultrasonography for detection of proximal deep vein thrombosis. (time frame: 48 hours window from detailed US). 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 30 Sep 2016.