Fuvid Study: Functional Characterization Following Venous Thromboembolic Disease

Why are we doing this research?

We don’t know why these physical complications happen after blood clots. We want to study whether the heart, lungs or muscle might be at play. We want to research and develop treatments for these problems.

Who can participate?

Patients who have a blood clot in the lungs are eligible to participate as study participants. The investigators also want to find out if the way heart and lung function when you exercise is different between the study and control participants.

You are eligible as a study participant for the study if all of these are true:

You have had a blood clot or pulmonary embolism in your lungs that:
- Affected the right side of your heart
- Caused your blood pressure to drop
- Caused you to collapse at diagnosis (also called intermediate-risk or high-risk pulmonary embolism)
You are between 8-21 years of age.
You are willing to participate and able to comply with the study protocol

You are not eligible as a study participant for the study if any of these are true:

If you have had a blood clot
- In the past (blood clots as an infant do not count) as a result of cancer
If you have any of the following conditions:
- Uncontrolled asthma, or you experience asthma symptoms daily (despite being on medication)
- Heart problems which have caused blood clots (and you are under the care of a pediatric cardiologist)
- Chronic kidney disease
- Chronic inflammatory or an autoimmune disorder (systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease or sickle cell disease)
- Metabolic or endocrinological disorder (such as diabetes mellitus or thyroid disorder)
- Contraindications to magnetic resonance imaging (MRI)
If you are not allowed to exercise for 4 months following the diagnosis of your most recent blood clot
If you are pregnant or are planning on becoming pregnant
You weigh 300 pounds or more
You did not receive blood thinners for the current blood clot (only for study participants)

Conditions

Hematology - Thrombosis

What will happen in the study?

By participating in this study, you will receive test results and detailed information regarding your body composition, lung functionality, exercise tolerance (or exercise capacity) and cardiac and lung imaging. The first screening visit will take place here at Cincinnati Children’s, and the second and third visits will occur in Dallas, Texas at UT Southwestern Medical Center that will last three days each. At the second and third visits, we will conduct exercise tests that involve points of exertion on a stationary bike while wearing a mouthpiece, DEXA (full body scan), and breathing tests as well as surveys, MRI of legs and cardiac exercise and blood tests.

Will you/your child be paid to be in this research study?

There is no guarantee or promise that you will receive any benefit from this study or from knowing the results of the research conducted. You will not be billed for anything related to the research visits and you will be compensated for your time.

Our Response to the IV Fluid Shortage

Clinical Trials / Research Studies
Clinical Trials / Research Studies