WHAT IS A CLINICAL TRIAL LIKE “ARUBA”?
A clinical trial is a scientific method for comparing different treatment approaches to see which one works best. In the ARUBA trial we want to learn if it is better to leave the AVM alone and simply treat the symptoms (medical management), as it has never bled, or to eliminate the AVM using one of several available techniques, including surgery, catheter embolization or radiation therapy. Although both medical management and interventional therapy have been used before to treat AVMs, they never have been compared to see which works best.
DO I HAVE TO TAKE PART IN THIS TRIAL?
No! All participation is voluntary. It is your decision whether or not to take part. You may want to discuss this with your family, friends, family doctor, or other doctors before you make up your mind whether to participate. Even if you do decide to take part, you can still change your mind and stop at any time. If you decide to stop your participation, please talk to us first. We can tell you about any other treatments, and help arrange for you to be treated outside of the trial.
WHY IS THIS TRIAL BEING DONE?
The risk of having an AVM of the brain is that it could rupture and bleed, possibly injuring the brain and causing symptoms of stroke. Removing or closing up an AVM by means of surgery, radiation therapy or interventional therapy can also injure brain tissue and cause a stroke. Current scientific data do not tell us conclusively whether there is less chance of brain injury when an unbled AVM is eliminated or is left alone.
HOW IS THE STUDY DONE, FOR HOW MANY AND FOR HOW LONG?
The question of which treatment approach is better, eliminating the unbled AVM or leaving it alone, can only be answered conclusively by performing a clinical trial. In a clinical trial, the treatments being compared are given to comparable groups of patients who, after receiving the treatment, are evaluated to determine which had a better outcome. Patients are assigned to treatments through a randomization process, like a coin toss, that helps to ensure that treatment groups are comparable. For the ARUBA trial there will be two groups of patients: those who undergo AVM elimination and those who will not. Patients assigned to the AVM elimination group will receive interventional therapy, either surgery, radiation therapy, or some combination of treatments, chosen by their doctor.
Enrolled patients will be followed for between 5 and 7.5 years depending on how long it takes to enroll the 800 patients needed for the trial. Enrolled patients are seen every 6 months for the first two years, and at least every year after that until the end of the study.
The trial plans to enroll patients from close to 100 different institutions in North America, Europe, Australia and South America.
ARE THERE RISKS TO THE STUDY?
There are risks in any study. The treatment risks are the same as they would be if you received any of the approved treatments being tested in ARUBA outside of the trial.
WHAT IF I WANT TO QUIT THE STUDY?
If you chose to take part in the study and change your mind later, you can stop participating in the research at any time. If you wish to withdraw your consent please inform your study doctor. All data collected up to the date you withdraw your consent will remain among the study records. If you decide to stop participation in this study it will not affect your health care.
WHAT IF I AM INTERESTED IN PARTICIPATING? WHO MAY I CONTACT FOR ADDITIONAL INFORMATION?
The following links will guide you to participating hospitals in many parts of the world. Doctors involved are among the best specialists in the field and will be happy to discuss any further details with you.United States & Canada