Ultrasound for Deep Vein Thrombosis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Pregnancy, Chronic DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will include approximately 50 patients who will be enrolled if there is suspicion of lower extremity deep vein thrombosis (DVT). Each patient will receive a point-of-care ultrasound performed by physicians in an outpatient clinic. All patients will receive a subsequent confirmatory gold standard venous duplex ultrasonography. The investigators will compare time to diagnosis and treatment initiation and evaluate short-term clinical outcomes, including pulmonary embolism, hospitalization, ICU care, and mortality.

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who are patients at Penn State Health and show symptoms of a deep vein thrombosis (DVT), such as leg pain or swelling. It's not specified who can't join, but typically those with conditions affecting the test accuracy would be excluded.

Inclusion Criteria

I am a patient at Penn State Health.

I am 18 years old or older.

I speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diagnosis

Participants receive a point-of-care ultrasound and a confirmatory venous duplex ultrasonography

1 week

2 visits (in-person)

Treatment

Initiation of treatment based on ultrasound results

1 week

Follow-up

Participants are monitored for safety and effectiveness after diagnosis and treatment

3 months

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests how quickly DVT can be diagnosed using point-of-care ultrasound (POCUS) by physicians in an outpatient setting, compared to the standard venous duplex ultrasonography. It aims to see if POCUS speeds up diagnosis and treatment initiation.

How Is the Trial Designed?

Group I: POCUS positive, Low risk, STAT DVT Experimental Treatment 1 Intervention

Patient who is low risk for DVT had a positive POCUS study in office was referred for STAT DVT study.

Group II: POCUS positive, High risk, STAT DVT Experimental Treatment 1 Intervention

Patient who is high risk for DVT had a positive POCUS study in office was referred for STAT DVT study.

Group III: POCUS negative, Low risk, Routine DVT Experimental Treatment 1 Intervention

Patient who is low risk for DVT had a negative POCUS study in office was referred for routine DVT study.

Group IV: POCUS negative, High risk, STAT DVT Experimental Treatment 1 Intervention

Patient who is high risk for DVT had a negative POCUS study in office was referred for STAT DVT study.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+