Pulmonary EmbolismNCT03532165
Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging
A study testing Lower extremity Ultrasound in people with Pulmonary Embolism and Deep Vein Thrombosis Leg, run by Albany Medical College at 1 site in United States.
Trial summary
At most institutions, the average patient with clinical concern for PE(pulmonary embolism) will have a CT angiogram(CTA) with contrast of the lungs performed to evaluate for a clot. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis Leg, Ultrasound Imaging
- What is being tested?
- Lower extremity Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 28 Feb 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical Concern for PE (moderate to high risk) that warrants imaging of the chest
Who cannot join
- Age less than 18
- nidus for DVT in upper extremity (eg. PICC (peripherally inserted central Cather) line, etc)
- already anti-coagulated at presentation
- above the knee- leg cast
- prisoners
- DVT ultrasound or CTA prior to presentation
Show all 12Show fewer
- Hemodynamically unstable:
- SBP (systolic blood pressure) <90 for >15min
- Drop of SBP by at least 40mmHG for >15mins
- Organ hypoperfusion (eg cold extremities, mental confusion, low urine outpt <30cc/hr, etc
- need for pressors
- Other concerns in thorax necessitating inevitable CT chest imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center Department of Emergency Medicine
Albany, New York, 12208
Dorcas B Pinto, MD, 518-262-3773, PintoD@amc.edu
Beth Cadigan, MD, 518-262-3773, CadigaB@amc.edu
About this study
At most institutions, the average patient with clinical concern for PE(pulmonary embolism) will have a CT angiogram(CTA) with contrast of the lungs performed to evaluate for a clot. However, CTA has risks including contrast- induced allergic reactions and nephropathy, as well as radiation which has been linked to development of cancer later in life. There is literature that has looked at using lower extremity doppler ultrasound first to evaluate for a DVT (deep venous thrombosis) in patients where there is concern for a PE. There is also literature showing that emergency medicine physicians can perform adequate lower extremity compression ultrasounds (LCUS), at the bedside with results similar to that of the ultrasound tech. The goal of this project is to fuse both principles by having emergency medicine physicians perform LCUS at the bedside, to help reduce CTA utilization in the evaluation of PE.
Read the detailed description
In this study, the subgroup of hemodynamically stable patients felt to be at moderate to high risk for PE will receive a bilateral LCUS before possible CTA/VQ imaging. The LCUS of the entire proximal leg including the popliteal fossa will be performed by an emergency medicine resident provider in conjunction with their attending. All positive studies will then be confirmed with a second ultrasound by the Albany Medical Center's vascular laboratory service. Patients with confirmed acute positive studies identifying a DVT will be treated for a presumed PE, which is the same treatment as that for the DVT. No CTA will be ordered from the ED. They will be anticoagulated and admitted to the hospital, with further management as per the inpatient hospital team. Patients with a negative emergency department LCUS done by the resident will receive either a CTA or a VQ (ventilation/perfusion) scan as per the initial treatment plan established by the attending physician.
According to this protocol, patients discharged home by default must have had a negative CTA or VQ scan, and so PE was effectively ruled out. Therefore they will not require further follow up after discharge. However, we will follow patients who were admitted throughout their admission course. Through review of medical records, we will take note of any complications such as any issues with starting anticoagulation treatment without a CTA, misdiagnoses, whether a CTA was ordered later as a part of their course and why, and further details.
- Being tested
- Lower extremity Ultrasound
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower extremity UltrasoundDiagnostic test
Also called CT angiogram of the chest
One group may forego a CT angiogram of the chest if they have a positive lower extremity ultrasound. The other group with a negative ultrasound may still require CT angiogram imaging.
| Study group | Role | What they receive |
|---|---|---|
| Positive lower extremity ultrasound | Other | This group found to to have a deep venous thrombosis on lower extremity ultrasound will not have a CT of the chest ordered from the emergency department, and will be treated for the DVT and presumed PE. Receives: Diagnostic Test: Lower extremity Ultrasound |
| Negative lower extremity ultrasound | Other | This group that does not have a deep venous thrombosis on lower extremity ultrasound will proceed to get the CT of the chest . Receives: Diagnostic Test: Lower extremity Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute reduction in CT imaging to diagnose PE
With the use of lower extremity ultrasound to diagnose DVT, some patients may forego the need for CT imaging while receiving appropriate care/treatment.
Measured: for duration of the study,about 1 year
Secondary outcomes (3)
Potential reduction in CT imaging to diagnose PE
If a CT is ordered on a patient with a positive lower extremity ultrasound by an inpatient physician later during the admission, we will calculate what the reduction in CT imaging would have been if the protocol had been followed to the end.
Measured: for duration of the study, about 1 year
Time to start of treatment
The use of bedside ultrasound may allow for making a diagnoses more quickly, and therefore potentially starting treatment sooner.
Measured: for duration of the study , about 1 year
Cost-analysis
The use of ultrasound may have less cost than using a CT scan
Measured: for duration of study, about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start2 Apr 2018
- Primary completion22 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- In all enrolled patients with concern for pulmonary embolism, a lower extremity ultrasound will be performed at the patient's bedside by the emergency room provider. If it is positive for a deep vein thrombosis, then a confimatory ultrasound will be performed by the vascular lab, and the patient started on anticoagulation to treat both the DVT and presumed PE. No CTA will be obtained in this group. Everyone else who had a negative bedside ultrasound performed by the ER provider will not receive a second ultrasound, but will rather go on to get the CT angiogram of the chest they would have likely received if not in the study.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorcas Boahema Pinto, Albany Medical College
- Investigators
- Dorcas B Pinto, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532165
- Sponsor's protocol ID
- 4975
- Status last verified
- May 2018
- First submitted
- 1 May 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skinner S. Pulmonary embolism: assessment and imaging. Aust Fam Physician. 2013 Sep;42(9):628-32.
PubMed 24024223Da Costa Rodrigues J, Alzuphar S, Combescure C, Le Gal G, Perrier A. Diagnostic characteristics of lower limb venous compression ultrasonography in suspected pulmonary embolism: a meta-analysis. J Thromb Haemost. 2016 Sep;14(9):1765-72. doi: 10.1111/jth.13407. Epub 2016 Aug 17.
PubMed 27377039Perrier A, Roy PM, Aujesky D, Chagnon I, Howarth N, Gourdier AL, Leftheriotis G, Barghouth G, Cornuz J, Hayoz D, Bounameaux H. Diagnosing pulmonary embolism in outpatients with clinical assessment, D-dimer measurement, venous ultrasound, and helical computed tomography: a multicenter management study. Am J Med. 2004 Mar 1;116(5):291-9. doi: 10.1016/j.amjmed.2003.09.041.
PubMed 14984813Poley 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 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bedside Ultrasound in Emergency Department Patients With Concern for Pulmonary Embolism to Reduce CT Imaging
- ClinicalTrials.gov ID
- NCT03532165
- Acronym / sponsor ID
- 4975
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 22 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 22 May 2018 (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.
At most institutions, the average patient with clinical concern for PE(pulmonary embolism) will have a CT angiogram(CTA) with contrast of the lungs performed to evaluate for a clot. However, CTA has risks including contrast- induced allergic reactions and nephropathy, as well as radiation which has been linked to development of cancer later in life. There is literature that has looked at using lower extremity doppler ultrasound first to evaluate for a DVT (deep venous thrombosis) in patients where there is concern for a PE. There is also literature showing that emergency medicine physicians can perform adequate lower extremity compression ultrasounds (LCUS), at the bedside with results similar to that of the ultrasound tech. The goal of this project is to fuse both principles by having emergency medicine physicians perform LCUS at the bedside, to help reduce CTA utilization in the evaluation of PE.
Detailed description
In this study, the subgroup of hemodynamically stable patients felt to be at moderate to high risk for PE will receive a bilateral LCUS before possible CTA/VQ imaging. The LCUS of the entire proximal leg including the popliteal fossa will be performed by an emergency medicine resident provider in conjunction with their attending. All positive studies will then be confirmed with a second ultrasound by the Albany Medical Center's vascular laboratory service. Patients with confirmed acute positive studies identifying a DVT will be treated for a presumed PE, which is the same treatment as that for the DVT. No CTA will be ordered from the ED. They will be anticoagulated and admitted to the hospital, with further management as per the inpatient hospital team. Patients with a negative emergency department LCUS done by the resident will receive either a CTA or a VQ (ventilation/perfusion) scan as per the initial treatment plan established by the attending physician.
According to this protocol, patients discharged home by default must have had a negative CTA or VQ scan, and so PE was effectively ruled out. Therefore they will not require further follow up after discharge. However, we will follow patients who were admitted throughout their admission course. Through review of medical records, we will take note of any complications such as any issues with starting anticoagulation treatment without a CTA, misdiagnoses, whether a CTA was ordered later as a part of their course and why, and further details.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In all enrolled patients with concern for pulmonary embolism, a lower extremity ultrasound will be performed at the patient's bedside by the emergency room provider. If it is positive for a deep vein thrombosis, then a confimatory ultrasound will be performed by the vascular lab, and the patient started on anticoagulation to treat both the DVT and presumed PE. No CTA will be obtained in this group. Everyone else who had a negative bedside ultrasound performed by the ER provider will not receive a second ultrasound, but will rather go on to get the CT angiogram of the chest they would have likely received if not in the study.
| Arm | Type | Receives |
|---|---|---|
| Positive lower extremity ultrasound | Other | Diagnostic Test: Lower extremity UltrasoundThis group found to to have a deep venous thrombosis on lower extremity ultrasound will not have a CT of the chest ordered from the emergency department, and will be treated for the DVT and presumed PE. |
| Negative lower extremity ultrasound | Other | Diagnostic Test: Lower extremity UltrasoundThis group that does not have a deep venous thrombosis on lower extremity ultrasound will proceed to get the CT of the chest . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical Concern for PE (moderate to high risk) that warrants imaging of the chest
Key exclusion criteria (12 listed)
- Age less than 18
- nidus for DVT in upper extremity (eg. PICC (peripherally inserted central Cather) line, etc)
- already anti-coagulated at presentation
- above the knee- leg cast
- prisoners
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 |
|---|---|---|
| Lower extremity UltrasoundAlso: CT angiogram of the chestOne group may forego a CT angiogram of the chest if they have a positive lower extremity ultrasound. The other group with a negative ultrasound may still require CT angiogram imaging. | Diagnostic test | Negative lower extremity ultrasound, Positive lower extremity ultrasound |
Primary outcome
Absolute reduction in CT imaging to diagnose PE
Time frame: for duration of the study,about 1 year
With the use of lower extremity ultrasound to diagnose DVT, some patients may forego the need for CT imaging while receiving appropriate care/treatment.
3 secondary outcomes
Potential reduction in CT imaging to diagnose PE
Time frame: for duration of the study, about 1 year
Time to start of treatment
Time frame: for duration of the study , about 1 year
Cost-analysis
Time frame: for duration of study, about 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Background: PubMed 24024223Skinner S. Pulmonary embolism: assessment and imaging. Aust Fam Physician. 2013 Sep;42(9):628-32.
- Background: PubMed 27377039Da Costa Rodrigues J, Alzuphar S, Combescure C, Le Gal G, Perrier A. Diagnostic characteristics of lower limb venous compression ultrasonography in suspected pulmonary embolism: a meta-analysis. J Thromb Haemost. 2016 Sep;14(9):1765-72. doi: 10.1111/jth.13407. Epub 2016 Aug 17.
- Background: PubMed 14984813Perrier A, Roy PM, Aujesky D, Chagnon I, Howarth N, Gourdier AL, Leftheriotis G, Barghouth G, Cornuz J, Hayoz D, Bounameaux H. Diagnosing pulmonary embolism in outpatients with clinical assessment, D-dimer measurement, venous ultrasound, and helical computed tomography: a multicenter management study. Am J Med. 2004 Mar 1;116(5):291-9. doi: 10.1016/j.amjmed.2003.09.041.
- Background: 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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.
Dorcas B Pinto, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower extremity Ultrasound in people with Pulmonary Embolism and Deep Vein Thrombosis Leg, run by Albany Medical College 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 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: status not confirmed, as of the sponsor's last update on 22 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorcas B Pinto, MD (518-262-3773, PintoD@amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute reduction in CT imaging to diagnose PE (time frame: for duration of the study,about 1 year). 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 NCT03532165, which also lists 4 linked publications.
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 22 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.