FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
Running, not enrolling
Conditions studied: Deep Venous Thrombosis, Pulmonary Embolism
In brief
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Key facts
- Study ID
- NCT04583878
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 115
- Starts
- 2020-12-22
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-06-08
Who can join
Age: 8 and older, up to 21. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ages 8 to ≤ 21 years
- 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.
You may not qualify if…
- Congenital heart disease with abnormal pulmonary circulation or with in-situ pulmonary artery thrombosis
- 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
- Additional exclusion criteria for participants with PE:
- Prior history of DVT or PE (upper extremity, cerebral sinus venous thrombosis and abdominal thromboses encountered as a neonate are not exclusion criteria)
- Lack of anticoagulant treatment for the acute VTE due to contraindications
Where it is running
- Arkansas Childrens Research Institute (ACRI) — Little Rock, Arkansas, United States
- 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
Full record on ClinicalTrials.gov
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