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CompletedNCT04597138Updated Jan 31, 2024

Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome

An observational study in Deep Vein Thrombosis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Mayo Clinic · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
35
Ages
18 Years and older
Sex
All
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Study summary

The goal of this study is to examine in vivo thrombosis characteristics with ultrasound shear wave elastography (SWE) and determine the relationship with thrombus resolution and postthrombotic syndrome (PTS) in patients with acute proximal Deep Vein Thrombosis (DVT).

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Conditions studied

  • Deep Vein Thrombosis

Keywords

  • Thrombus Resolution
  • Post-Thrombotic Syndrome
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In context

Thrombosis

1,508 studies on the registry are indexed under Thrombosis; 239 are open to participants now.

This study's enrollment of 35 is below the median of 213 across 588 observational studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute, proximal DVT initiating anticoagulation

Inclusion criteria

  • Diagnosis of acute, proximal (popliteal and above) DVT with or without Pulmonary Embolism within 72 hours
  • ≥18 Years Old

Exclusion criteria

Exclusion Criteria

  • prior episode of DVT
  • contraindication to standard therapeutic anticoagulation
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Thrombus Resolution

    Ultrasound images of lower extremity DVTs comparing the initial diagnostic image of thrombus to a subsequent study performed after 3 months of anticoagulation.The lower extremity venous system is divided into 12 segments. Each vein segment will be analyzed on initial ultrasound and recorded 0 (no DVT), 1 (non-occlusive DVT), or 2 (occlusive DVT). The follow up ultrasound will be analyzed per vein segment and recorded as no residual thrombus, minimal chronic post-thrombotic changes, \> 50% resolution, \< 50% resolution, near occlusive DVT, no change, and progressive DVT.

    Time frame: 3 Months after diagnosis of DVT.

Secondary outcomes

  1. Post-thrombotic syndrome

    Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.

    Time frame: 6 months after diagnosis of DVT

  2. Vein Specific Quality of Life

    Measured using The Venous Insufficiency Epidemiological and Economic Study (VEINES) QOL survey. Scores range from 0-100 with higher scores indicating better quality of life.

    Time frame: 6 months after diagnosis of DVT

Other outcomes

  1. Post-thrombotic syndrome

    Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.

    Time frame: 3 and 12 months after diagnosis of DVT

  2. Vein Specific Quality of Life

    Measured using The Venous Insufficiency Epidemiological and Economic Study (VEINES) QOL survey. Scores range from 0-100 with higher scores indicating better quality of life.

    Time frame: 3 and 12 months after diagnosis of DVT

  3. Thrombus Resolution

    Measured quantitatively by outflow parameters on air plethysmography with expelled volume measured at 1 second x 60 sec (ml/100ml/minute), expelled volume after 4 seconds, and maximum volume expelled.

    Time frame: 3 Months after diagnosis of DVT.

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Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04597138
Lead sponsor
Mayo Clinic
Responsible party
Damon E. Houghton (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 22, 2020
Start date
Nov 2, 2020
Primary completion
Oct 17, 2023
Completion
Oct 17, 2023
Last update
Jan 31, 2024

Study contacts

Damon Houghton, MD
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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