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

Completed

• Conditions: Deep Vein Thrombosis

• Registration Number: NCT04597138
• Lead Sponsor: Mayo Clinic

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Study Start: 2020-11-02
• Primary Completion: 2023-10-17
• Study Completion: 2023-10-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States