Published in UAB Insight, Summer 2008
NIH-Funded Consortium Trials Test Prehospital Interventions
Two large collaborative clinical trials at UAB and nine other centers throughout the United States and Canada are investigating new therapies for treatment of severe traumatic injury and out-of-hospital cardiac arrest (OOHCA). The trials are part of the Resuscitation Outcomes Consortium (ROC), a National Institutes of Health-funded clinical network conducting multiple collaborative trials.
ROC investigations will translate scientific and clinical advances to the prehospital setting to improve outcomes in a variety of emergent situations. ROC's organizational structure requires cooperation among a complex network of emergency medical services, public safety agencies, regional hospitals, community health care institutions, and medical centers. As many as 15,000 people will participate.
Studies in seriously injured patients with emergent conditions are necessary to test promising treatments for use in the prehospital setting, says UAB trauma surgeon Jeffrey D. Kerby, MD, PhD, principal investigator for UAB's ROC trials. "The therapeutic window for these conditions is narrow, and the earlier we administer effective treatment the greater the potential for improvements in outcomes," he says.
ROC's goal is to provide a substantial prehospital network to evaluate therapies that have shown promise in preclinical settings but need study in clinical trials.
Examples include optimal fluid resuscitation strategies, use of resuscitative adjuncts (eg, estrogen), use of immunomodulating agents to reduce secondary injury, improved strategies for hemorrhage control, and optimal prehospital ventilation strategies. These also can be studied in OOHCA along with alternative cardiopulmonary resuscitation (CPR) methods, hypothermia following OOHCA, and improved resuscitation and emergency medicine training techniques.
Informing the Community
Because ROC studies take place in the emergency setting among people with severe conditions, informed consent cannot be obtained from the majority of those enrolled. The trials use an exemption from the informed consent process outlined by the Food and Drug Administration (FDA). Known as the "Final Rule," the exemption allows research in emergency situations for clinical trials that meet very rigid criteria.
The rule requires an aggressive community consultation and public disclosure plan that includes mechanisms to inform the community of study specifics and to obtain community feedback regarding the conduct of trials. Those who do not wish to participate in the trials have the opportunity to opt out.
"Our community consultation and public disclosure efforts to date include presentations at 14 area city council meetings, 115 newspaper articles, 28 television news stories, 202,000 household mailings, radio news stories, interviews, and presentations at public meetings," Kerby says.
Lifesaving Interventions in the Field
ROC research occurs in the context of bleak epidemiological statistics. Cardiovascular disease remains the leading cause of death in the United States. Most of these are sudden cardiac deaths that occur outside of the hospital. Nearly 450,000 people experience OOHCA annually, and 95% of those treated die. "There are more annual out-of-hospital cardiac arrests deaths than deaths from automobile accidents, HIV, and cerebrovascular diseases combined," Kerby says. The survival rate in Alabama is 2%.
"CPR, defibrillation, and other established treatments for cardiac arrest and traumatic injury have not produced anticipated increases in survival," says UAB ROC Project Director Shannon W. Stephens, EMT-P. Likewise, traumatic injury is the leading cause of death in patients aged 1 to 44 years and is the number one cause of years of productive life lost.
The initial UAB ROC trauma study involves evaluation of alternative resuscitation fluids in traumatic brain injury and severe hemorrhagic shock. This study compares the effectiveness of three initial resuscitation fluids (7.5% hypertonic saline and dextran, 7.5% hypertonic saline alone, and normal saline) on survival from shock and survival and functional outcome in participants with traumatic brain injury.
The first cardiac trial will compare a longer course of CPR prior to defibrillation with the current standard of care. It also will evaluate use of an impedance threshold device, which enhances venous return and cardiac output by increasing negative intrathoracic pressure during decompression. "The key to improved survival from out-of-hospital cardiac death may be increasing and speeding circulation of oxygenated blood to the heart and brain," Stephens says.
The trauma and cardiac arrest trials will conclude enrollment in early 2010, adding to cardiac arrest and traumatic injury surveillance data UAB has collected since 2005.
"These epidemiologic data have already produced several key findings," Kerby says. "With research infrastructure in place in the prehospital setting, we are uniquely positioned to perform current and future studies in the out-of-hospital setting. Our goal is to keep the local medical community on the cutting edge of treatments that improve survival and functional outcomes."
Since emergency medical services personnel perform both patient enrollment and study interventions, these trials could not be done without a great deal of local support from the Birmingham Regional Emergency Medical Services System and the participating emergency medical services. "We greatly appreciate their support for our trials, which offer great hope for bringing better treatments to patients with emergency conditions," Kerby says.
Emergency Medical Services Enrolling Patients in ROC Trials:
- Alabama Life Saver
- Bessemer Fire Department
- Birmingham Fire and Rescue Service
- Center Point Fire District
- Chelsea Fire and Rescue Department
- Hoover Fire Department
- Moody Fire Department
- Pelham Fire Department
- Regional Paramedic Services
- Rocky Ridge Fire District
- Trussville Fire and Rescue
- Vestavia Hills Fire Department
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Alabama Resuscitation Center • 205.934.9532
Resuscitation Outcomes Consortium
FOR MORE INFORMATION:
Dr. Jeffrey Kerby
Shannon Stephens
1.800.UAB.MIST
mist@uabmc.edu