FUVID Study Recruitment

The FUVID Study: Functional Characterization of Children with Chronic Venous Thromboembolic Disease
[ ClinicalTrials.gov Identifier: NCT04583878 ]

fuvid

The FUVID Study is currently open for enrollment to qualified participants.

Start the Eligibility Survey

What happens after blood clots?

  1. Incomplete physical recovery after blood clots in the lungs or legs
  2. Exercise intolerance and shortness of breath affects many children and young adults after blood clots in the lungs and legs
  3. A patient’s daily life after he/she survives blood clots in the lungs or legs is not often the same as before the blood clots occur

Why is a study needed?

  • 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

There are two ways to participate in this study!

As a study participant or as a control participant

Patients who have a blood clot in the lungs are called study participants, and those who have not had a blood clot are control 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.

Who is eligible to participate in the FUVID research study?

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

  • You have had a blood clot or pulmonary embolism in your lungs
  • You are between 8-21 years of age
  • You are willing to participate and able to comply with the study protocol

You are eligible as a control participant if all of these are true:

  • You have been asked to limit your activity for at least 2 weeks (but no more than 12 weeks) following minor surgery or injury.

You are not eligible as a study or control participant 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)

 

What will happen if I decide to join the research study?

Visit 1
(in-person or virtual visit)

Timing of Enrollment

  • Occurs as soon as the minor surgery or injury limiting activity is diagnosed and up to 60 days following the surgery or injury
  • May occur while you are in the hospital or be combined with your doctor appointment (especially if your doctor is part of our study) (everyone)

 

You will be asked to:

  • Fill out electronic questionnaires (everyone)
  • Provide blood specimens (only for study participant and based on location)

 

Visit 2
(both study and control participants)

Timing of appointment

  • Scheduled within 2-3 months after Visit 1
  • Research visit

Location of appointment

  • You will be required to visit Children’s Medical Center located in Dallas, Texas
  • Research will be conducted over 3 consecutive days in order to complete all necessary procedures

During your appointments, you will:

  • Fill out additional questionnaires
  • Perform an exercise test (stationary bicycle)
  • Perform lung function tests
  • Take an MRI of your lungs, heart, and legs
  • Provide additional blood specimens

Visit 3
(both study and control participants)

Timing of appointment

  • Scheduled within 9-10 months after Visit 2
  • Research visit

Location of appointment

  • You will be required to visit Children’s Medical Center located in Dallas, Texas
  • Research will be conducted over 3 consecutive days in order to complete all necessary procedures

During your appointments, you will:

  • Fill out additional questionnaires
  • Perform an exercise test (stationary bicycle)
  • Perform lung function tests
  • Take an MRI of your lungs, heart, and legs
  • Provide additional blood specimens

Expenses

The FUVID study will compensate you for your time and related expenses, including travel to Dallas, Texas, hotel stay, meals, and transportation between airport, hotel, and Children’s Medical Center. For participants who are minors, costs associated with one parent or legal guardian will also be covered.

How will the study benefit me?

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.

There is no guarantee or promise that you will receive any benefit from this study or from knowing the results of the research conducted.

About the Center for Cancer and Blood Disorders, Children’s Medical Center and UTSW Pediatric Group

Learn more about the Pauline Allen Gill Center for Cancer and Blood Disorders (CCBD).

Learn more about Children's Medical Center Dallas.

Learn more about UT Southwestern Pediatric Group.

Questions?

To learn more about participation or eligibility, please email the study team.

Funding Sources