Deep Vein ThrombosisNCT04597138
Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome
An observational study of Deep Vein Thrombosis, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 17 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute, proximal DVT initiating anticoagulation
Who may be able to join
- Diagnosis of acute, proximal (popliteal and above) DVT with or without Pulmonary Embolism within 72 hours
- ≥18 Years Old
Who cannot join
- prior episode of DVT
- contraindication to standard therapeutic anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between 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).
- Conditions
- Deep Vein Thrombosis
- Keywords
- Thrombus Resolution, Post-Thrombotic Syndrome
- Medical subject headings
- Venous Thrombosis, Postthrombotic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months after diagnosis of DVT.
Secondary outcomes (2)
Post-thrombotic syndrome
Measured using the Villalta Score. Scale 0-33 with higher values indicating more severe symptoms.
Measured: 6 months after diagnosis of DVT
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.
Measured: 6 months after diagnosis of DVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start2 Nov 2020
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damon E. Houghton, Mayo Clinic
- Investigators
- Damon Houghton, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597138
- Sponsor's protocol ID
- 20-002573
- Status last verified
- Jan 2024
- First submitted
- 15 Oct 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Deep Venous Thrombus Characteristics and Venous Dynamics With Subsequent Thrombus Resolution and Post-thrombotic Syndrome
- ClinicalTrials.gov ID
- NCT04597138
- Acronym / sponsor ID
- 20-002573
- Conditions
- Deep Vein Thrombosis
- Keywords
- Thrombus Resolution, Post-Thrombotic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute, proximal DVT initiating anticoagulation
Key inclusion criteria (2 listed)
- Diagnosis of acute, proximal (popliteal and above) DVT with or without Pulmonary Embolism within 72 hours
- ≥18 Years Old
Key exclusion criteria (2 listed)
- prior episode of DVT
- contraindication to standard therapeutic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Post-thrombotic syndrome
Time frame: 6 months after diagnosis of DVT
Vein Specific Quality of Life
Time frame: 6 months after diagnosis of DVT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon Houghton, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Vein Thrombosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombus Resolution (time frame: 3 Months after diagnosis of DVT.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.