Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay

NCT03038893 | Completed

• 1 other identifier: 54321516.0.0000.5327
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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 (POCUS + EDUS), and the control group was submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.

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

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Length of hospital stay

  Up to 30 days

Secondary Outcomes (2)

• Time to first diagnostic information

  Up to 30 days

• Time to therapeutic decision making / prescription

  Up to 30 days

Study Arms (2)

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.

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.

Diagnostic Test: Echo Doppler Ultrasound (EDUS)

Interventions

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.

POCUS + EDUS

Echo Doppler Ultrasound (EDUS) DIAGNOSTIC_TEST

Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.

Echo Doppler Ultrasound (EDUS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low, moderate or high suspicion of DVT by Wells Criteria.
• Patients with Echo-Doppler Ultrasonography already requested in the hospital system.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ana Claudia Tonelli

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single Blind Masking
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 1, 2017
• Study Start: August 1, 2016
• Primary Completion: November 30, 2016
• Study Completion: January 30, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01