AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

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 groups in NCT03038893
Study groupRoleWhat they receive
POCUS + EDUSExperimentalPatients 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 comparatorPatients 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.

  1. Length of hospital stay

    Length of hospital stay

    Measured: Up to 30 days

Secondary outcomes (2)
  1. Time to first diagnostic information

    Time to first diagnostic information

    Measured: Up to 30 days

  2. 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.

  1. First posted1 Feb 2017 (estimated)
  2. Study start1 Aug 2016
  3. Primary completion30 Nov 2016
  4. Study completion30 Jan 2017

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in