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

Description

This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.

Conditions

Deep Venous Thrombosis, Pulmonary Embolism

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Study Overview

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Study Details

Study overview

This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.

FUVID Study: a Multi-center, Prospective Study Evaluating Exercise Intolerance and Dyspnea on Exertion in Patients Following First-episode Deep Venous Thrombosis and Pulmonary Embolism

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

Condition
Deep Venous Thrombosis
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Childrens Research Institute (ACRI), Little Rock, Arkansas, United States, 72202

Saint Petersburg

Johns Hopkins All Childrens Hospital, Saint Petersburg, Florida, United States, 33701

Atlanta

Emory University / Children's Heathcare Atlanta, Atlanta, Georgia, United States, 30329

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Mount Pleasant

Central Michigan University, Mount Pleasant, Michigan, United States, 48859

Kansas City

Childrens Mercy Hospital, Kansas City, Missouri, United States, 64108

Cincinnati

Cincinnati Childrens Hospital, Cincinnati, Ohio, United States, 45229

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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

Ages Eligible for Study

8 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Ayesha Zia, MD, MSCS, PRINCIPAL_INVESTIGATOR, University of Texas Southwestern Medical Center

Study Record Dates

2024-12