Newswise — Today marks the official launch of a massive Canada-U.S. research collaboration aimed at dramatically improving survival rates after cardiac arrest and severe trauma when they occur in the community.
Canadian and U.S. research funding agencies are partnering in the Resuscitation Outcomes Consortium (ROC), an ambitious multi-year program to conduct a large number of tightly-coupled clinical trials.
The ROC will involve public safety agencies, regional hospitals, community healthcare institutions, tertiary care centers and may include as many as 15,000 patients per year over a three-year period. Emergency medical services, as well as fire services, will be an integral part of the research network that will conduct clinical trials of potential new treatments for cardiac arrest and severe traumatic injury that occur in Canadian and U.S. communities.
The Canadian Institutes of Health Research (CIHR) " Institute of Circulatory and Respiratory Health, Defence Research and Development Canada (DRDC) and the Heart and Stroke Foundation of Canada (HSFC) are working in collaboration with the National Heart, Lung, and Blood Institute, the lead U.S. agency, the National Institute of Neurological Disorders and Stroke, the U.S. Department of Defense and the American Heart Association. Initial funds of $50 million USD have been committed to the Consortium.
There are an estimated 40,000 incidents of cardiac arrests each year in Canada, most of which take place out of hospital settings. The odds of survival for an out-of-hospital arrest are a dismal 5%. Severe injury is also a major public health problem. About 14,000 fatal injuries occur each year in Canada. And for every patient who dies there are another three patients who are severely disabled in North America.
"Far, far too many Canadians die each year from sudden cardiac arrest and traumatic events that occur in the public, at home, and in the workplace. The good news is that there is a growing body of research " basic research and small studies " that suggests a significant number of these people can be saved," said Dr. Bruce McManus, Scientific Director with the CIHR Institute of Circulatory and Respiratory Health. "For the first time we will know, based on large and well designed studies, what interventions really make a difference."
Within the ROC, two committees have been established to develop clinical trials that address different aspects of trauma and cardiac arrest. The first study will test the use of saline solutions similar to the body's own fluids on trauma patients and the second will test the effectiveness of a new device administered during cardiopulmonary resuscitation (CPR) to enhance blood flow.
In addition to the clinical trials, the Consortium is currently enrolling patients into a new database of all cardiac arrest and trauma events that occur in communities. This will be the first ongoing, multi-city comprehensive database with information about how field treatment leads to patient survival.
All of the interventions to be tested in the new program have in many instances been shown in smaller, single center studies to be safe and to potentially have a life-saving effect. The Consortium's testing of new techniques, as well as well-known techniques, will provide the large-scale proof of effectiveness needed to support widespread adoption and use across both Canada and the U.S., and perhaps elsewhere.
"It is gratifying to see the successful launch of a major bilateral effort between Canada and the United States to improve the survival and clinical outcome of trauma victims," said Dr. Pang Shek, Head Operational Medicine, DRDC. "This research has profound implications for implementing better resuscitation strategies for civilian and military casualties alike."
"This is the first time we've established a collaborative group to do large-scale clinical trials to improve the treatment of patients with traumatic injury and cardiac arrest in communities," says Dr. Jim Christenson, Heart and Stroke Foundation spokesperson. "Large multi-center studies in patients with heart attacks and heart failure have answered questions about the best treatments. As a result, we've seen greatly improved survival for these disorders. That's what we want to do with cardiac arrest and traumatic injury."
Dr. Ian Stiell (University of Ottawa, Ottawa Health Research Institute) is the lead investigator for the Ottawa and Vancouver, British Columbia sites, while Dr. Arthur Slutsky (University of Toronto) is the lead investigator for Toronto and the Greater Toronto Area.
Backgrounder
Cardiac ArrestIn cardiac arrest, the heart stops beating effectively, blood does not circulate and no pulse can be felt. The victim collapses suddenly into unconsciousness. Heart attacks, which are caused by a blockage of a coronary artery, can sometimes lead to cardiac arrest. A common underlying cause of sudden cardiac arrest is an abrupt disorganization of the heart's rhythm called ventricular fibrillation, which can be triggered by a heart attack or can just represent a catastrophic rhythm disturbance. Unless cardiac arrest victims are treated within minutes (by defibrillation to shock an abnormally beating heart back into normal rhythm or CPR followed by or in conjunction with other procedures), they will die. There are an estimated 40,000 cardiac arrests each year in Canada, most of which take place out of hospital settings. The odds of survival for an out of hospital arrest are a dismal 5%.
Severe TraumaSevere injury is also a major public health problem. Almost 14,000 fatal injuries occur each year in Canada. And, for every patient who dies there are another three patients who are severely disabled in North America. The leading causes of death following injury are brain injury, blood loss, and organ failure from excessive inflammation. The ROC seeks to investigate early therapies which will both save lives and reduce disability for the severely injured. The results of these civilian studies are applicable in the military environments well, as the causes of death are similar.
Clinical TrialsThe first treatments to be tested will be highly concentrated forms of a saline solution similar to the body's own fluids. Trauma patients with either signs of blood loss or severe brain injury will receive one of three saline solutions - standard saline, high concentration saline, or high concentration saline with dextran, a circulation-enhancing substance. The two concentrated solutions are designed to replace blood loss more effectively, lessen excessive inflammatory responses and prevent brain swelling. This could lead to a reduction in organ failure for patients with major blood loss and improved function for patients with brain injury.
The second study will test a device to enhance blood flow during CPR. This device is a one-way valve that fits between the airbag used to introduce air into a person in cardiac arrest and the flexible plastic tube that goes through the nose or mouth and into the lungs to help with breathing. The valve can also be used with a facemask that goes over the patient's nose and mouth. During CPR, the one-way valve creates a small vacuum inside the patient's chest, which increases the return flow of blood to the heart.
Other possible future studies include testing of new drug approaches to aid resuscitation from cardiac arrest and evaluation of novel strategies to control hemorrhage.
In a typical study scenario, a ROC emergency responder (Fire or EMS) will arrive at the scene of the cardiac arrest or trauma and confirm the patient's diagnosis. The emergency responder will then assess whether the patient meets the entrance criteria for the study and if so, treat the patient with the study intervention.
Since the studies will be blinded, the emergency responders in the field will not know which treatment the patient receives. For example, in the first consortium study testing the concentrated saline solutions, all solutions of saline to be administered to patients will look alike, although they will be numbered for later identification and analysis by the study's scientists.
Clinical Trials GuidelinesIn addition to rigorous review by an independent review group, the clinical trials of the new Consortium will be conducted under strict FDA and Health Canada guidelines that allow for patients in life threatening situations to participate in research without standard informed consent. The guidelines specify criteria that must be followed for a study to have an exception from informed consent. These include:
* Approval by an institutional research ethics board, a committee of experts and lay people established to review research. * Notification of patients who were involved in the research.* Oversight by an independent group of experts charged with monitoring the research for safety and early efficacy.
Participating Sites* Ottawa, Ontario: University of Ottawa (includes 17 additional cities)* Vancouver, British Columbia: University of British Columbia (includes 20 additional cities)* Toronto, Ontario: University of Toronto (includes Greater Toronto Area)* Dallas,TX: University of Texas Southwestern Medical Center (Dallas and surrounding cities to participate)* Iowa City, IA: University of Iowa (includes 10 cities throughout Iowa)* Milwaukee, WI: Medical College of Wisconsin* Pittsburgh,PA: University of Pittsburgh Medical Center (includes several suburbs)* Portland, OR: Oregon Health and Sciences University (includes 4 counties)* Seattle and King County, WA: University of Washington* Birmingham,AL: University of Alabama at Birmingham (Central and possibly Northern Alabama)* San Diego, CA: University of California, San Diego (entire county)
The study is coordinated by investigators at the University of Washington, Seattle.
The Canadian Institutes of Health Research (http://www.cihr-irsc.gc.ca)The Canadian Institutes of Health Research (CIHR) is the Government of Canada's agency for health research. CIHR's mission is to create new scientific knowledge and to catalyze its translation into improved health, more effective health services and products, and a strengthened Canadian health care system. Composed of 13 Institutes, CIHR provides leadership and support to close to 10,000 health researchers and trainees across Canada.
CIHR Institute of Circulatory and Respiratory Health is devoted to funding research and researchers focused on etiology, mechanisms, prevention, detection, treatment, rehabilitation, and palliation of diseases of heart, lung, blood vessel (including stroke), blood, sleep, and critical care.
Defence Research and Development Canada (http://www.drdc-rddc.gc.ca)Defence Research and Development Canada (DRDC) is an agency of the Department of National Defence responding to the scientific and technological needs of the Canadian Forces (CF). Its mission is to ensure that the CF remains technologically prepared and operationally relevant. With a broad scientific program, DRDC actively collaborates with the private sector, academia, other government departments, international allies, and the national security community to maximize research benefits to the CF, industry and ultimately all Canadians.
The Heart and Stroke Foundation (http://www.heartandstroke.ca)The Heart and Stroke Foundation is a leading funder of heart and stroke research in Canada. The Foundation's mission is to improve the health of Canadians by preventing and reducing disability and death from heart disease and stroke through research, health promotion and advocacy. Improving resuscitation outcomes is a strategic priority of the Foundation.
For more information, please visit the Resuscitation Outcomes Consortium Web site: https://roc.uwctc.org
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