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

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597138
• Other study ID #: 20-002573
• Status: Completed
• Start date: November 2, 2020
• Est. completion date: October 17, 2023

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-thrombotic syndrome	Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.	3 and 12 months after diagnosis of DVT
Other	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.	3 and 12 months after diagnosis of DVT
Other	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.	3 Months after diagnosis of DVT.
Primary	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.	3 Months after diagnosis of DVT.
Secondary	Post-thrombotic syndrome	Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.	6 months after diagnosis of DVT
Secondary	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.	6 months after diagnosis of DVT

External Links

•   Mayo Clinic Clinical Trials