FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Oct 9, 2020

Keywords

ClinConnect Summary

The FUVID Study is a research trial aimed at understanding how chronic venous thromboembolic disease affects children who have experienced their first episode of deep venous thrombosis (a blood clot in a deep vein) or pulmonary embolism (a blood clot that travels to the lungs). The study is currently recruiting participants aged 8 to 21 who can speak and understand English. Eligible participants include those with acute pulmonary embolism, and there are also control groups of children who are recovering from minor surgeries or injuries, as well as healthy children without any activity restrictions.

If you or your child join this study, you’ll be closely monitored over time to learn more about how these conditions impact daily activities and overall health. It's important to note that certain health issues, such as congenital heart disease, chronic kidney disease, or recent serious asthma problems, may prevent participation. The goal of the trial is to gather valuable insights that can help improve care for young patients with these conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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