C-TRACT Study

STUDY BASICS

Did you have a blood clot in your leg that occurred more than 3 months ago? Do you now have leg heaviness, fatigue, swelling, aching, or pain—a condition called post-thrombotic syndrome? If so, you may be eligible to participate in a research study to help find out if certain medical procedures can reduce the severity of post-thrombotic syndrome and improve quality of life. Compensation provided.

STUDY PURPOSE

A deep vein thrombosis, or DVT, is a blood clot in a deep vein that most commonly occurs in the legs. After a DVT, many people experience a complication called post-thrombotic syndrome—a condition that can include pain, swelling, heaviness, fatigue, skin changes, and open sores on the legs. Current treatments for post-thrombotic syndrome include elastic compression stockings and devices, exercise, and medications. The purpose of this research study is to find out if catheter-based endovascular therapy procedures can reduce the severity of post-thrombotic syndrome and improve patients’ quality of life. Catheter-based endovascular therapy procedures include stent placement to prop open the vein and endovenous ablation to block the vein. Researchers hope their findings will lead to better ways to treat people with post-thrombotic syndrome in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Diagnosed with a blood clot in the leg that occurred more than 3 months ago
• Currently have leg ulcers, heaviness, fatigue, swelling, aching, or pain

WHAT PARTICIPANTS CAN EXPECT

Participation lasts up to 2 years and includes multiple visits. Participants will have two pre-study enrollment visits to find out if they are eligible for this research study. During these visits, a member of the study team will review your medical records, health history, and medications, perform a physical exam, collect a small amount of blood, perform imaging to assess venous blood flow, and will ask you to complete questionnaires about your post-thrombotic syndrome symptoms and quality of life. If eligible after these visits, participants will be randomly assigned (like the flip of a coin) to receive either standard post-thrombotic syndrome care or standard post-thrombotic syndrome care plus endovascular therapy. Participants assigned to the second group will return in one week for a procedure. Patients in both groups will return for visits at 2 months, 4 months, 6 months, 12 months, 18 months, and 24 months.