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
1 other identifier
observational
35
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2023
CompletedJanuary 31, 2024
January 1, 2024
3 years
October 15, 2020
January 30, 2024
Conditions
Keywords
Outcome Measures
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.
3 Months after diagnosis of DVT.
Secondary Outcomes (2)
Post-thrombotic syndrome
6 months after diagnosis of DVT
Vein Specific Quality of Life
6 months after diagnosis of DVT
Other Outcomes (3)
Post-thrombotic syndrome
3 and 12 months after diagnosis of DVT
Vein Specific Quality of Life
3 and 12 months after diagnosis of DVT
Thrombus Resolution
3 Months after diagnosis of DVT.
Eligibility Criteria
Patients with acute, proximal DVT initiating anticoagulation
You may qualify if:
- Diagnosis of acute, proximal (popliteal and above) DVT with or without Pulmonary Embolism within 72 hours
- ≥18 Years Old
You may not qualify if:
- prior episode of DVT
- contraindication to standard therapeutic anticoagulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damon Houghton, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 15, 2020
First Posted
October 22, 2020
Study Start
November 2, 2020
Primary Completion
October 17, 2023
Study Completion
October 17, 2023
Last Updated
January 31, 2024
Record last verified: 2024-01