Research

FUVID Study Recruitment

FUVID Study logo (abstract person running)

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

ClinicalTrials.gov Identifier: NCT04583878 ]



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 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 ELIGIBLE AS A CONTROL PARTICIPANT IF ALL OF THESE ARE TRUE:

  • You have been asked to limit your activity for at least 4 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

Timing of appointment

  • Occurs within 4 weeks of the diagnosis of your blood clot (study participant) or 4 weeks following minor surgery or injury (control participant)
  • 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 (may require overnight hotel stay)
  • 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 (may require overnight hotel stay)
  • 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.

Meet the FUVID Study Team

FUVID Study Team Member Ayesha Zia (headshot) Ayesha Zia, MD, MSCS
Principal Investigator
Associate Professor of Pediatrics, UT Southwestern Medical Center

FUVID Study Team Member Kendra Malone (headshot) Kendra Malone, MPH CCRP
Research Coordinator
Children's Health

Anna Winborn, CCRC
Research Coordinator
Children's Health

FUVID Study Team Member Lorrie Burkhalter (headshot) Lorrie Burkhalter, MPH, CCRC
Program Manager
UT Southwestern Medical Center

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.