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Completed

NCT Number: NCT04597138

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

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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Key information

Conditions

Deep Vein Thrombosis Cardiovascular Diseases Embolism and Thrombosis Postthrombotic Syndrome Thrombosis Vascular Diseases Venous Insufficiency Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • prior episode of DVT
  • contraindication to standard therapeutic anticoagulation

Treatment and study plan

Primary outcomes

  1. Thrombus Resolution

    Time frame: 3 Months after diagnosis of DVT.

    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.

Secondary outcomes

  1. Post-thrombotic syndrome

    Time frame: 6 months after diagnosis of DVT

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

  2. Vein Specific Quality of Life

    Time frame: 6 months after diagnosis of DVT

    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.

Other outcomes

  1. Post-thrombotic syndrome

    Time frame: 3 and 12 months after diagnosis of DVT

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

  2. Vein Specific Quality of Life

    Time frame: 3 and 12 months after diagnosis of DVT

    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.

  3. Thrombus Resolution

    Time frame: 3 Months after diagnosis of DVT.

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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