Why are research studies important and how do they benefit people?
Carefully evaluating patients who are treated in research studies is the best way for doctors to learn what the best treatments are for patients with post-thrombotic syndrome (PTS) and other medical conditions. The C-TRACT Study is comparing two treatment strategies for PTS to determine which is best. If we get the answer from this study, doctors will be better able to help the many thousands of people who develop PTS each year.
Why would I want to participate in a research study?
Like most studies of medical treatments, there is no guarantee that you will experience a benefit from participating in the C-TRACT Study. But consider the following points:
Before a patient is enrolled in the study, the study team first carefully reviews his/her medical history. Patients who have medical conditions that put them at higher risk for complications are not offered study participation. The risks and possible benefits from participating in the study are carefully explained to patients before they are enrolled, and all questions are answered. This process is called “informed consent”. Patients may choose whether or not to participate, and can withdraw from the study at any time.
In the C-TRACT study, treatments for PTS are delivered to patients using methods that have been endorsed by national physician experts. Depending on the individual patient, treatments that may be used include medications that prevent clotting or reduce inflammation, compression stockings and other compression methods, and/or procedures to open blocked veins or eliminate backwards blood flow (reflux). The plan for doing the study was reviewed and approved by scientific experts convened by the National Institutes of Health.
The doctors who conduct the C-TRACT Study were selected from a pool of applicants because of the outstanding expertise of their local team of doctors, the high quality of their hospitals, and their track record in doing studies. Many are national leaders in the care of DVT and PTS.
Study patients are closely monitored by a team of expert doctors in PTS care, and also have easy access to a study nurse to answer questions about the study and their PTS. This study nurse can be very helpful in providing information and in coordinating care. The study team reviews patients’ progress regularly and tailors treatment as needed – this may include adjusting existing medications or leg compression, or trying new methods.
Studies have shown that among patients who receive warfarin (a blood-thinning drug) for DVT treatment, those who are enrolled in a research study are more likely to be at the correct level of blood-thinning than those who are not in a study. This may be due to the close monitoring and frequent communication of study patients with the study team.
Therefore, participating in the C-TRACT Study is a great way for a person with PTS to receive an outstanding level of care while also helping other people with PTS.
For more information on participating in research studies, visit The Center for Information & Study on Clinical Research Participation.