Deep Venous ThrombosesNCT03038893
Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay
A study testing Point Of Care Ultrasound (PODUS) and Echo Doppler Ultrasound (EDUS) in people with Deep Venous Thromboses and Deep Venous Thrombosis of Left Leg, run by Hospital de Clinicas de Porto Alegre.
Trial summary
This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of Care Ultrasound and Echo Doppler Ultrasound… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Venous Thromboses, Deep Venous Thrombosis of Left Leg, Deep Venous Thrombosis of Right Leg
- What is being tested?
- Point Of Care Ultrasound (PODUS) and Echo Doppler Ultrasound (EDUS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 30 Jan 2017
- 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
- Low, moderate or high suspicion of DVT by Wells Criteria.
- Patients with Echo-Doppler Ultrasonography already requested in the hospital system.
Who cannot join
- Myocardial Infarction, Stroke or Cardiac Surgery within 3 months prior to hospital admission;
- Renal Chronic Disease (Clinical Stages IV and V);
- Congestive Heart Failure (NYHA IV);
- Pregnancy;
- Previous episode of DVT in the same leg that of the current DVT suspicion;
- Patients already in treatment for DVT or taking anticoagulants for any other reason.
About this study
This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.
Read the detailed description
Because of high mortality associated with venous thrombosis (pulmonary embolism and deep venous thrombosis - DVT) the early recognition and therapeutics of its condition are crucial. Point of Care Ultrasound (POCUS) is a method with high sensibility to diagnose DVT and it is as accurate as Echo Doppler Ultrasound (EDUS), however the use of POCUS for diagnosis of DVT in the emergency care still presents resistance. This is a Clinical Trial on the use of POCUS for the diagnosis of DVT and its effect on length of hospital stay. 25 participants were randomized into two groups. The randomization was done through the random.org site in blocks of 4, a randomization list was with one researcher (blind) of the study. The experimental group was first submitted to POCUS in the Emergency Room, performed by a resident physician of Internal Medicine with training in POCUS, then after submitted to EDUS in the Radiology Service by a Radiologist. The control group was submitted only to EDUS in the Radiology Service. The 2-point compression technique was used, as described in previous studies, using the portable ultrasound device (M-turbo Sonosite) with a high frequency linear transducer (5-10 MHZ). The sites used in the evaluation were the popliteal site comprising the popliteal vein and trifurcation of the popliteal vein and the femoral point in which comprises the sapheno-femoral junction, the common femoral vein and the superficial femoral vein, all evaluated in the transverse plane. The result was considered positive for DVT when the vessel evaluated showed no compressibility and / or presented echogenic material in the lumen of the vein. After the randomization, the patients were followed for a period of 30 days, being evaluated in three moments: initial evaluation, at 7 and 30 days of the initial evaluation. Whenever possible, each evaluation was in person. In the initial evaluation, the participant's demographics, date and time of arrival at the Emergency Service, previous illnesses, Wells criteria score and reason for the initial care were collected. Participants randomized to the POCUS + EDUS group had recorded date and time of ultrasound at the bedside and, if there was confirmation of DVT, these data were collected by the resident physician, blinded for the Echo Doppler Ultrasound results. EDUS data, such as date and time of the examination request, date and time of the release of the exam report, confirmation of DVT, date and time of discharge were collected by another researcher, blinded to the participant's group and to the POCUS's results. After 7 and 30 days the outcomes were recorded: time for a first diagnostic information, time to therapeutic decision making / prescription, length of hospital stay, death, pulmonary thromboembolism, bleeding or other complication, re-hospitalization, evolution to DVT in cases that were initially negative.
- Conditions
- Deep Venous Thromboses, Deep Venous Thrombosis of Left Leg, Deep Venous Thrombosis of Right Leg, Deep Venous Thrombosis Proximal
- Being tested
- Point Of Care Ultrasound (PODUS), Echo Doppler Ultrasound (EDUS)
- Keywords
- Ultrasonography, Point-of-care systems, Deep venous thrombosis, Hospitalization
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point Of Care Ultrasound (PODUS)Diagnostic test
Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
Echo Doppler Ultrasound (EDUS)Diagnostic test
Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
| Study group | Role | What they receive |
|---|---|---|
| POCUS + EDUS | Experimental | Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT. Receives: Diagnostic Test: Point Of Care Ultrasound (PODUS) |
| Echo Doppler Ultrasound (EDUS) | Active comparator | Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT. Receives: Diagnostic Test: Echo Doppler Ultrasound (EDUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay
Measured: Up to 30 days
Secondary outcomes (2)
Time to first diagnostic information
Time to first diagnostic information
Measured: Up to 30 days
Time to therapeutic decision making / prescription
Time to therapeutic decision making / prescription
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Aug 2016
- Primary completion30 Nov 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Claudia Tonelli, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038893
- Sponsor's protocol ID
- 54321516.0.0000.5327
- Status last verified
- Jan 2017
- First submitted
- 31 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay
- ClinicalTrials.gov ID
- NCT03038893
- Acronym / sponsor ID
- 54321516.0.0000.5327
- Conditions
- Deep Venous Thromboses, Deep Venous Thrombosis of Left Leg, Deep Venous Thrombosis of Right Leg, Deep Venous Thrombosis Proximal
- Keywords
- Ultrasonography, Point-of-care systems, Deep venous thrombosis, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 1 Feb 2017 (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.
This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.
Detailed description
Because of high mortality associated with venous thrombosis (pulmonary embolism and deep venous thrombosis - DVT) the early recognition and therapeutics of its condition are crucial. Point of Care Ultrasound (POCUS) is a method with high sensibility to diagnose DVT and it is as accurate as Echo Doppler Ultrasound (EDUS), however the use of POCUS for diagnosis of DVT in the emergency care still presents resistance. This is a Clinical Trial on the use of POCUS for the diagnosis of DVT and its effect on length of hospital stay. 25 participants were randomized into two groups. The randomization was done through the random.org site in blocks of 4, a randomization list was with one researcher (blind) of the study. The experimental group was first submitted to POCUS in the Emergency Room, performed by a resident physician of Internal Medicine with training in POCUS, then after submitted to EDUS in the Radiology Service by a Radiologist. The control group was submitted only to EDUS in the Radiology Service. The 2-point compression technique was used, as described in previous studies, using the portable ultrasound device (M-turbo Sonosite) with a high frequency linear transducer (5-10 MHZ). The sites used in the evaluation were the popliteal site comprising the popliteal vein and trifurcation of the popliteal vein and the femoral point in which comprises the sapheno-femoral junction, the common femoral vein and the superficial femoral vein, all evaluated in the transverse plane. The result was considered positive for DVT when the vessel evaluated showed no compressibility and / or presented echogenic material in the lumen of the vein. After the randomization, the patients were followed for a period of 30 days, being evaluated in three moments: initial evaluation, at 7 and 30 days of the initial evaluation. Whenever possible, each evaluation was in person. In the initial evaluation, the participant's demographics, date and time of arrival at the Emergency Service, previous illnesses, Wells criteria score and reason for the initial care were collected. Participants randomized to the POCUS + EDUS group had recorded date and time of ultrasound at the bedside and, if there was confirmation of DVT, these data were collected by the resident physician, blinded for the Echo Doppler Ultrasound results. EDUS data, such as date and time of the examination request, date and time of the release of the exam report, confirmation of DVT, date and time of discharge were collected by another researcher, blinded to the participant's group and to the POCUS's results. After 7 and 30 days the outcomes were recorded: time for a first diagnostic information, time to therapeutic decision making / prescription, length of hospital stay, death, pulmonary thromboembolism, bleeding or other complication, re-hospitalization, evolution to DVT in cases that were initially negative.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCUS + EDUS | Experimental | Diagnostic Test: Point Of Care Ultrasound (PODUS)Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT. |
| Echo Doppler Ultrasound (EDUS) | Active comparator | Diagnostic Test: Echo Doppler Ultrasound (EDUS)Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low, moderate or high suspicion of DVT by Wells Criteria.
- Patients with Echo-Doppler Ultrasonography already requested in the hospital system.
Key exclusion criteria (6 listed)
- Myocardial Infarction, Stroke or Cardiac Surgery within 3 months prior to hospital admission;
- Renal Chronic Disease (Clinical Stages IV and V);
- Congestive Heart Failure (NYHA IV);
- Pregnancy;
- Previous episode of DVT in the same leg that of the current DVT suspicion;
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 |
|---|---|---|
| Point Of Care Ultrasound (PODUS)Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT. | Diagnostic test | POCUS + EDUS |
| Echo Doppler Ultrasound (EDUS)Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT. | Diagnostic test | Echo Doppler Ultrasound (EDUS) |
Primary outcome
Length of hospital stay
Time frame: Up to 30 days
Length of hospital stay
2 secondary outcomes
Time to first diagnostic information
Time frame: Up to 30 days
Time to therapeutic decision making / prescription
Time frame: Up to 30 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 1 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ana Claudia Tonelli principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Point Of Care Ultrasound (PODUS) and Echo Doppler Ultrasound (EDUS) in people with Deep Venous Thromboses and Deep Venous Thrombosis of Left Leg, run by Hospital de Clinicas de Porto Alegre.
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 6 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Length of hospital stay (time frame: Up to 30 days). 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 1 Feb 2017.