Welcome to the C-TRACT Study
C-TRACT stands for:
Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy
What is the C-TRACT Trial?
C-TRACT is a large, well-designed study of new treatments for vein damage caused by blood clots. The goal of the study is to understand whether new image-guided procedures (endovascular therapy or EVT) reduce the severity of Post-Thrombotic Syndrome (PTS) and improve quality of life. The long-term safety and costs of the EVT procedure(s) will also be considered. Findings from the study may change how doctors care for patients with PTS. If volunteers who underwent EVT procedures as part of the study have improved symptoms and quality life, clinicians may consider offering EVT procedures more frequently as part of their treatment plan. If EVT proves ineffective or unsafe, the findings from this study may reduce or eliminate the use of unnecessary and expensive procedures.
Why are new treatment options for PTS important?
The Post-Thrombotic Syndrome (PTS) is a frequent (40%) chronic complication of having a blood clot within a deep vein of the body (DVT). Many patients experience one or more the following symptoms of PTS:
- chronic leg heaviness of the leg
- leg fatigue
- leg swelling (“edema”)
- leg aching or pain
- changes of skin color on the leg
Some patients develop open sores (venous leg ulcers)
In some cases, symptoms can be managed with modest lifestyle changes (e.g. rest periods with leg elevation described below). However, when symptoms become more severe, PTS can result in work disability, inability to perform household tasks, and major impairment of health-related quality of life.
- What EVT treatments are being studied in the C-TRACT Trial?
- Placement of metallic stents into the blocked vein in your pelvis that normally provides drainage of blood flow from the leg.
- Closure (endovenous ablation) of backwards-flowing veins in your leg that have leaky valves
National Recognition for PTS Research
The C-TRACT Trial is sponsored by the National Heart Lung and Blood Institute (NHLBI), a part of the National Institutes of Health – one of the most highly-respected research organizations in the world. The need for the C-TRACT trial has been endorsed by multidisciplinary organizations including the American College of Phlebology, American Venous Forum, North American Thrombosis Forum, Society of Interventional Radiology Foundation, and Society for Vascular Medicine. There is broad consensus that C-TRACT addresses a health question of major importance to patients, physicians, and the U.S. healthcare system.
Why participate in C-TRACT?
The C-TRACT Trial is actively recruiting volunteers. To meet the goals of the study, we need to enroll and follow 374 patients with moderate-to-severe PTS and blockage of the large veins draining the leg. Important study points if you are considering research participation:
For C-TRACT, volunteers will be randomly assigned (like the flip of a coin) to either high quality PTS care (lifestyle interventions, compression therapy, and medical therapy) or high quality PTS care AND endovascular therapy (stent placement to re-open blocked veins and, if needed, endovenous ablation to eliminate backflow in veins with leaky valves).
After randomization, patients will be asked to return to their clinical research center for study visits at 2 Months, 4 Months, 6 Months, 12 Months, 18 Months, and 24 Months.
Enrolled study participants will receive a $100 stipend after each scheduled follow-up visit that they attend – starting after the 4 Month follow up visit.
Taking part in this research study is completely voluntary. You may choose not to take part at all. If you decide to be in this study, you may stop participating at any time.
Am I eligible to participate in C-TRACT?
To ensure safe participation, interested individuals will be screened carefully to ensure they have meet the condition we are studying. If you answer “yes” to all the following questions, you may be eligible to participate in the C-TRACT Trial:
- Are you ≥ 18 years of age or older?
- Have you been diagnosed with blood clot in your leg in the past (more than 3 months ago)?
- Do you now have chronic leg heaviness, fatigue, swelling, aching, pain, or skin changes?
If you answered “yes” to all 3 questions, you may be a perfect fit to participate in the C-TRACT Study, in which national physician experts in PTS and endovascular treatment are currently enrolling patients to determine the best treatment for blood clots.
C-TRACT has approximately 25 Clinical Centers in the U.S. Locate a research center closest to you.
The Post-Thrombotic Syndrome (PTS) is a frequent (40%) chronic complication of having a blood clot within a deep vein of the body (DVT). Many patients experience one or more the following symptoms of PTS on a daily basis:
- leg heaviness
- leg tiredness or fatigue
- leg swelling (“edema”)
- leg aching or pain
- Changes in skin color or texture
A small number of patients develop skin breakdown (“ulcers”).
In some cases, symptoms can be managed with modest lifestyle changes (e.g. rest periods with leg elevation).
Many treating physicians prescribe anticoagulant medication to prevent Post-Thrombotic Syndrome (PTS) by reducing the risk of recurrent DVT and/or elastic compression stockings to reduce inflammation.
Often, PTS develops frequently despite the use of these medications.
PTS is difficult to treat effectively. Treatment that are often used include:
- Elastic Compression Stockings
- Devices that improve circulation in the leg, called intermittent pneumatic compression or portable return assist devices;
- Supervised exercise programs
- Use of venoactive medications to improve blood flow; and
- Catheter-based endovascular procedures