ROC - ALPS
Frequently Asked Questions
- What is the Resuscitation Outcomes Consortium (ROC)?
- What is the purpose of this study?
- Why is a placebo included in one of the randomization arms?
- Where will the study be conducted?
- How many patients will be enrolled in the study?
- When will the study start?
- How long will it take to complete the study?
- How do patients enter the study?
- How can research be done on a person without the person's permission?
- What is exception from informed consent?
- If a family member is present when the patient has a cardiac arrest, why is the family not asked for permission?
- Are there any risks to the patient?
What is the Resuscitation Outcomes Consortium (ROC)?
The Resuscitation Outcomes Consortium (ROC) is a national research group studying better ways to treat people who have cardiac arrest or severe injury due to trauma.
Cardiac arrest is when the heart suddenly stops beating. The person collapses suddenly and is unconscious. Severe trauma can be related to car accidents or other causes.
ROC tests drugs and other new ways for treating people. We want to find out if new types of care can better help people who are very ill. ROC studies are being done in Emergency Medical Services (EMS) systems in 10 regions in the United States and Canada.
These studies are paid for by the National Institutes of Health (NIH). Some funding also comes from the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, Defense Research and Development Canada, the Heart and Stroke Foundation of Canada, and the American Heart Association.
What is the purpose of this study?
The goal of ALPS is to see if we can help more people survive after a cardiac arrest. We will see how many people survive until it's time to leave the hospital. We will compare 3 types of treatment in patients with cardiac arrest that do not respond to standard care including shocks to the heart. Patients will have an equal chance of being in any group.
- Group 1: Amiodarone, a standard heart rhythm medication or
- Group 2: Lidocaine, another standard heart rhythm medication or
- Group 3: No medication (placebo - salt water solution)
Why is a placebo included in one of the randomization arms?
Doctors often use heart rhythm medications (Amiodarone, Lidocaine) to treat abnormal heart rhythms (arrhythmias) during a cardiac arrest. However, we do not know if any of these medicines improve the chances of survival. We do not know if these drugs cause more harm than good.
Where will the study be conducted?
The study will take place at 10 locations across the U.S. and Canada including our local area, the Portland/Vancouver metropolitan area.
How many patients will be enrolled in the study?
About 3,000 patients will take part in the United States and Canada.
When will the study start?
The study is currently underway. The first patient was enrolled in June, 2012.
How long will it take to complete the study?
We expect the study to last about 3 years.
How do patients enter the study?
Patients may enter ALPS if they have a cardiac arrest outside of the hospital and someone calls 911. Cardiac arrest happens without warning. Because of this, a person cannot sign up ahead of time to be in this study. Patients will be unable to speak or hear (unconscious) and are without signs of life when they are enrolled in the study. Emergency responders must give life-supporting treatments immediately in the field to save their life. Patients are too sick to consent to this treatment.
How can research be done on a person without the person's permission?
There are serious medical situations where patients are unconscious so they are unable to give us their permission to take part in a study. Cardiac arrest is one of those situations. We will carry out the ALPS study under federal regulations that allow us to do this research without consent.
What is exception from informed consent?
In 1996, the Food and Drug Administration (FDA) created specific rules that allow for emergency research without getting consent from a patient first. This is because there are some emergency medical situations where there is no time for patients or family members to give consent before treatment. These rules allow important emergency care research to take place.
According to FDA regulations, you do not have to get consent first when the research study involves people who suffer from a life-threatening disease or injury, current treatment is not effective, and often results in death anyway. Finally, the research must show the possibility of helping patients directly. ROC studies are reviewed by different groups to make sure that they meet the highest ethical standards.
If a family member is present when the patient has a cardiac arrest, why is the family not asked for permission?
There isn't time. In order to agree to be in a study, the person must understand what is being said to them, and make a well-informed decision. Family members are usually very upset during a medical emergency. They may not be able to concentrate or understand what is being said. Cardiac arrest is an extreme emergency -- the patient will die within a few minutes if treatment is not started right away.
Are there any risks to the patient?
Whenever we use a new treatment, there are risks. We will carefully monitor patient safety during this study, and keep track of any problems from the study treatments. Possible reactions to the study drugs include seizures, a severe drug allergy, or a slow heart beat that may require a pacemaker (a small device placed under your skin to speed up your heart beat). Patients may also have a reaction to the drug that causes redness, warmth, tenderness or a hard swelling under your skin where the drug entered the body. These are the same risks that anyone who uses these drugs during cardiac arrest are exposed to. One reason we are doing this study is to see if these risks are worth the possible benefit of the drugs. We may find out that avoiding these drugs entirely may be the best treatment.