ROC - HypoResus
Frequently Asked Questions
- What is the Resuscitation Outcomes Consortium (ROC)?
- What is the purpose of this study?
- 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?
- Once the injured patient reaches the emergency department, will the patient and/or family member be told about the study?
- Are there any risks to the patient?
What is the Resuscitation Outcomes Consortium (ROC)?
The Resuscitation Outcomes Consortium (ROC) is a clinical research network of 10 Regional Clinical Centers (RCCs) and a Data Coordinating Center (DCC) that is studying better ways to help people who have cardiac arrest or severe traumatic injury in the out-of-hospital setting. Cardiac arrest is the loss of mechanical activity of the heart, causing the heart to suddenly stop beating effectively. Blood does not circulate, no pulse can be felt, and the patient collapses suddenly into unconsciousness. Severe traumatic injury is injury with very low blood pressure and altered level of consciousness or brain injury. The studies test if the use of promising drugs, tools, and techniques in real-world settings improves outcomes for these critically ill patients. ROC studies are being done in Emergency Medical Services (EMS) systems in 10 regions or cities in the United States and Canada.
The National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) is the lead sponsor of the ROC studies. Additional funding is provided by the, Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, the US Army Medical Research and Materiel Command, 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 purpose of this pilot study is to determine whether hypotensive resuscitation for the early treatment of patients with traumatic shock is better than standard fluid resuscitation.
Patients who are severely injured and in shock are suspected to be bleeding either internally or through external wounds. There are two schools of thought regarding how to treat these patients. The current standard is to give lots of fluid through an intravenous line thinking that this will keep the blood pressure up. It is now suspected that too much fluid may not help the bleeding and in fact might actually increase bleeding by popping established clots off of holes in blood vessels. Patients in this study will either receive large bags of fluid (normal saline which is fluid with the same saltiness as your blood) at a rapid rate or receive no fluid or if necessary smaller amounts of fluid through prehospital care and in the emergency room for the first two hours of care or until the bleeding is controlled.
Where will the study be conducted?
The study will be done at 7 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?
A total of 200 patients will be enrolled across all participating ROC sites in the United States and Canada.
When will the study start?
The study is currently underway. The first patient was enrolled at OHSU in July 2012. The start time will be different at each of the ROC sites depending on when they receive local approval to begin the study.
How long will it take to complete the study?
The study is expected to last approximately one year once all sites have begun enrolling.
How do patients enter the study?
Patients in this study have had a severe traumatic injury. Traumatic injuries occur unexpectedly and because of the inability to predict when a traumatic injury is going to occur, a person cannot sign up ahead of time. Patients will either be unconscious (unable to speak or hear) or in shock when they are enrolled in the HypoResus trial. Life-supporting interventions must be given immediately in the field by the paramedics. Patients are too sick to consent to immediate treatment. Therefore, the paramedics will enroll patients with a low blood pressure into the study by opening a package and seeing if there is a big bag of fluid in the package or a small bag of fluid. The packages will be randomly packed with big or small bags like flipping a coin.
How can research be done on a person without the person's permission?
There are serious medical emergency situations where patients are too sick or unconscious to give permission to be enrolled in a study. Severe traumatic injury is one of those situations. The HypoResus study will be conducted under federal regulations that allow an exception from informed consent.
What is exception from informed consent?
In 1996, the Food and Drug Administration (FDA) developed specific regulations to permit emergency research without prospective consent under carefully controlled circumstances. This is in recognition of the unique kind of emergency medical situations in which patients or family members cannot give informed consent before treatment as well as the need to allow emergency care to advance through research.
According to FDA regulations, to qualify for an exception from informed consent, the research study must involve participants suffering from a life-threatening disease process or injury for which the current standard of care is associated with a very high failure or mortality rate. In addition, there must be reasonable evidence that the research has the potential to provide real and direct benefit to the patient. Studies must be held to the highest ethical standards. The ROC studies have undergone many independent rigorous reviews to ensure that they meet these standards.
The use of a randomized clinical trial such as this is the "gold standard" for determining what works best for people. For treatments that must be given immediately to be effective, exception from informed consent research is considered appropriate by federal regulatory bodies and many ethicists who study this field. The obligation to improve standard treatments that yield poor results in life-threatening conditions is also considered an ethical imperative, as is maintaining individual rights of citizens. In exception from informed consent trials, citizens received standard treatment in addition to research treatment. To be tested in this fashion, the research treatment has to have shown promise in earlier or smaller studies.
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 give permission to participate in a study, it is important that the person giving permission understands what is being said to them, and can make a well-informed decision. Family members are usually very upset during a medical emergency and are not able to concentrate or comprehend what is being said during the emergency. Severe traumatic injury is an extreme emergency during which the patient could potentially die if treatment is not begun immediately. Patients suffering a traumatic injury may be unconscious or too sick to discuss their treatment, and any time taken to discuss their treatment with family deprives the patient of immediately starting life-saving measures.
Once the injured patient reaches the emergency department, will the patient and/or family member be told about the study?
The study treatment will continue when the patient arrives in the emergency department for the first 2 hours or until hemorrhage is controlled, whichever comes first. If it is feasible during this time period, an attempt will be made to obtain informed consent from the patient's legally authorized representative, family member, or directly from the patient, if possible. If informed consent is not obtained before the end of the study treatment, no further efforts will be made. However, notification of the patient's enrollment in the study will be attempted while the patient remains in the hospital. At that time the patient, the patient's legally authorized representative or family member will be given the opportunity to withdraw the patient from further study participation and will be provided instruction for how to do so.
Are there any risks to the patient?
As is possible with any new treatment, there are risks involved. Patient safety is carefully monitored and recorded for any complications of study treatments. The patients in this study will be selected to receive standard fluid administration versus reduced fluid administration. In theory, reduced fluid administration could result in decreased blood flow to the vital organs which may cause them to stop working properly, increased risks of infection, and death. Increased fluid administration may cause increased bleeding, blood clotting problems, and increased risks of organ failure and death.