FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
NCT ID: NCT04583878
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
115 participants
OBSERVATIONAL
2020-12-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Participants with Pulmonary Embolism
The target accrual is based on the primary endpoint (exercise intolerance and dyspnea on exertion). To achieve adequate power and precision in the primary analysis, the target enrollment is 80 children. Both males and females of all races and ethnic groups are eligible for this study.
Blood draw (Visit 1)
Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
Blood draw (Visits 2 and 3)
Labs will be drawn at Visit 2 (12 weeks post-diagnosis with a range of 10-16 weeks) and Visit 3 (12 months ± 30 days) for research purposes only and will be collected at Children's Medical Center and processed at UT Southwestern Medical Center.
Control Group
A positive control group that has not had pulmonary embolism (PE) but is prescribed physical activity restrictions expected to produce a similar deconditioning effect as patients with PE will be enrolled from UT Southwestern only (cohort 1) or children who are no prescribed physical activity restrictions and are otherwise considered healthy (cohort 2). The target accrual of the positive control group is based on feasibility and availability of funds and will be limited to 25 controls.
Blood draw (Visits 2 and 3)
Labs will be drawn at Visit 2 (12 weeks post-diagnosis with a range of 10-16 weeks) and Visit 3 (12 months ± 30 days) for research purposes only and will be collected at Children's Medical Center and processed at UT Southwestern Medical Center.
Interventions
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Blood draw (Visit 1)
Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
Blood draw (Visits 2 and 3)
Labs will be drawn at Visit 2 (12 weeks post-diagnosis with a range of 10-16 weeks) and Visit 3 (12 months ± 30 days) for research purposes only and will be collected at Children's Medical Center and processed at UT Southwestern Medical Center.
Eligibility Criteria
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Inclusion Criteria
* Participant must be able to speak and understand English
* Be willing to participate and able to comply with the study protocol
* For participants with PE: Children with acute, radiologically confirmed pulmonary embolism (PE) with our without DVT
* For control group: Cohort 1: Children who are prescribed physical activity restrictions for 2 up to 12 weeks following any minor outpatient surgery or, minor injury (surgery or injury is referred to as "diagnosis" hereafter) Cohort 2: Children who are not prescribed physical activity restrictions and are otherwise considered to be healthy.
Exclusion Criteria
* Chronic kidney disease
* Chronic inflammatory or an autoimmune disorder (such as systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease, and sickle cell disease)
* A metabolic or endocrinological disorder such as diabetes mellitus or thyroid disorder
* History of or active cancer
* Pregnant
* Musculoskeletal limitations to exercise expected to be present uptil 4 months post-diagnosis
* Weight ≥ 300 lbs
* Contraindications to magnetic resonance imaging
* Frequent severe exacerbations of asthma defined by two or more bursts of systemic glucocorticoids (more than three days each) in the previous year or at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year. Patients should also be excluded if there are daily symptoms of asthma requiring daily use of short-acting bronchodilators such as albuterol or levalbuterol administration. The use of controller medications such as daily inhaled corticosteroids for mild persistent asthma is not exclusionary.
* Has any other medical condition, which in the opinion of the investigator may potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical study
* Lack of anticoagulant treatment for the acute VTE due to contraindications
8 Years
21 Years
ALL
Yes
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Ayesha Zia
Associate Professor of Pediatrics
Principal Investigators
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Ayesha Zia, MD, MSCS
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Johns Hopkins All Childrens Hospital
St. Petersburg, Florida, United States
Emory University / Children's Heathcare Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Central Michigan University
Mount Pleasant, Michigan, United States
Childrens Mercy Hospital
Kansas City, Missouri, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center / Children's Medical Center
Dallas, Texas, United States
Cook Childrens Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Arkansas Childrens Research Institute (ACRI)
Little Rock, Arkansas, United States
Countries
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Related Links
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FUVID Website
Other Identifiers
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STU-2020-0868
Identifier Type: -
Identifier Source: org_study_id
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