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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04597138

Enrollment

Registered

2020-10-22

Start date

2020-11-02

Completion date

2023-10-17

Last updated

2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis

Keywords

Thrombus Resolution, Post-Thrombotic Syndrome

Brief 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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Thrombus Resolution	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

Measure	Time frame	Description
Post-thrombotic syndrome	6 months after diagnosis of DVT	Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.
Vein Specific Quality of Life	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

Measure	Time frame	Description
Post-thrombotic syndrome	3 and 12 months after diagnosis of DVT	Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.
Vein Specific Quality of Life	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.
Thrombus Resolution	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.

Countries

United States

Outcome results