University Of Pittsburgh Study Aims To Improve Survival From Cardiac Arrest And Severe Trauma
Notification of community consultation for emergency medicine research
PITTSBURGH, June 15, 2006 — A young mother is unconscious and bleeding from internal injuries from a highway accident. A soldier is severely injured in a roadside explosion. A 50-year-old man suffers cardiac arrest while he gets ready for work. In such situations, the chance of survival from life-threatening injury and cardiac arrest is abysmal; many more could survive if only they could be kept alive long enough to reach the hospital. However, most cardiac arrest victims die before they reach the hospital, making traumatic injury a leading cause of death in North America among persons between the ages of one and 44 years.
In an effort to determine how to increase the chances of survival from both cardiac arrest and trauma, emergency medicine researchers from the University of Pittsburgh School of Medicine, in collaboration with UPMC Trauma Services, are participating in a 10-city international trial, known as the Resuscitation Outcomes Consortium (ROC).
In the cardiopulmonary resuscitation (CPR) phase of the trial, patients will be randomized to receive one of two methods of resuscitation. Upon arriving at the scene of a patient in cardiac arrest, paramedics will either first shock the patient with an external defibrillator, or perform three minutes of CPR before delivering the rescue shock. It is thought that CPR may help prepare the heart for a rescue shock. In the second arm of this study, paramedics will provide oxygen to the patient using a one-way air valve while performing manual chest compressions. The air valve increases the blood pressure generated by chest compressions, improving blood circulation to the heart and brain during CPR. Neither the patients nor paramedics will know whether the face mask being used contains an active valve until the study is completed.
In the trauma phase of the trial, patients with either severe head injury or shock from blood loss will be randomized to initially receive a single bag of one of three types of resuscitative fluids: a standard saline solution, which currently is used for most trauma cases; a concentrated saline solution; or a concentrated saline solution mixed with Dextran, which acts as a circulatory enhancer. The researchers hope administering these resuscitative fluids as early as possible will reverse shock and reduce brain swelling in the prehospital setting, improving survival and brain function after traumatic brain injury. If additional fluids are needed prior to arrival to the hospital, the standard saline solution will be administered.
“In order to determine best practice examples for treating cardiac arrest and trauma, emergency medicine research is essential,” says Clifton Callaway, M.D., Ph.D., associate professor of emergency medicine at the University of Pittsburgh School of Medicine and principal investigator of the Pittsburgh CPR study. “Patients enrolled in this landmark study will benefit by receiving cutting edge emergency medicine research provided by top-trained EMS personnel.”
The trauma study will be led by Samuel Tisherman, M.D., associate professor of surgery and critical care medicine at the University of Pittsburgh School of Medicine.
Because this study could affect anyone living in the areas served by participating EMS agencies, the study investigators and the University have been seeking comments from both civic leaders and the public. To explain the research and answer questions, the Pitt researchers have established a local website at www.emsresearch.org that provides information about the risks and benefits of the study.
According to federal law and university policy, those who participate in most clinical research studies must provide informed consent. Because of the nature of this trial, it is impossible to obtain consent at the time of cardiac arrest or trauma. For this reason, the researchers are adhering to U.S. Department of Health and Human Services guidelines that allow for patients in life-threatening situations to be enrolled in a clinical study during emergency situations. The research has been reviewed and approved independently by the University’s Institutional Review Board for clinical research.
The Pitt researchers have notified both county officials and community leaders about the informed consent process. The researchers will make every attempt to inform family members and, if possible, the patients themselves, to provide notification and obtain consent for continued patient tracking after subject enrollment.
Both methods of CPR in the cardiac arrest trial and the three study solutions in the trauma trial are within the standards for prehospital care so patient safety will not be compromised during the course of this study. Patients who survive to hospital discharge will receive follow up evaluations at one, three and six month intervals.
The University of Pittsburgh was selected to participate in this landmark, multi-city clinical research consortium because of its long-standing history as a premiere academic medical center that performs bench to bedside research in resuscitative medicine and its unique relationship with local EMS services. For more than 25 years, the department of emergency medicine and local EMS have collaborated on several research projects that have greatly benefited the citizens of Pittsburgh and surrounding communities and saved countless lives.
The Resuscitation Outcomes Consortium was created to advance clinical research in the areas of CPR and traumatic injury and consists of 10 participating cities in the United States and Canada, including Birmingham, Ala.; Dallas; Iowa City, Iowa; Milwaukee, Wis.; Ottawa; Pittsburgh; Portland, Ore.; San Diego; Seattle; and Toronto.