Jul 11 2006
UT Southwestern Medical Center is among 10 institutions selected to oversee innovative clinical trials designed to test life-saving interventions for critical trauma and sudden cardiac arrest.
The National Institutes of Health has joined with other U.S. and Canadian agencies to fund the $50 million Resuscitation Outcomes Consortium (ROC) and establish federal resuscitation research centers in 10 North American regions.
The centers are expected to enroll as many as 20,000 total patients (15,000 with cardiac arrest and 5,000 with major trauma) over the next two to three years. The Dallas Center for Resuscitation Research is coordinated through UT Southwestern.
This summer, in cooperation with dozens of Dallas-area receiving hospitals, paramedics and emergency medical technicians in the BioTel System will begin administering the new interventions on-site or in the ambulance. BioTel, a coalition of emergency medicine providers serving more than a dozen Dallas area cities, receives medical oversight from UT Southwestern's emergency medicine program.
Dr. Ahamed Idris, professor of emergency medicine and a pioneer in resuscitation research and cardiopulmonary resuscitation (CPR), is the principal investigator for the Dallas Center for Resuscitation Research.
"This NIH designation not only is a great honor that places the Dallas area on the cutting-edge of life-saving research," said Dr. Idris, "but it also will immediately benefit our citizens because of the additional support, training, equipment and focus that this federal initiative will bring to the Dallas area."
In the study, trauma patients with 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 saline solutions take advantage of the body's own fluids to help rapidly restore circulation in bleeding patients.
In the case of cardiac arrest, patients will be treated with a unique airway valve called the "inspiratory threshold device." The device is a one-way valve that fits between the breathing bag and facemask used for lung ventilation. This simple airway attachment is designed to significantly enhance blood flow back to the chest during CPR and, in turn, enhance the blood flow out to the heart and brain.
Both interventions have been studied in hundreds of patients in preliminary, single- or multi-center studies and have been demonstrated to be safe and to potentially have lifesaving effects.
But, because patients will be critically ill and unable to give consent, a series of educational meetings are being held to inform the public about the studies. People who want to be excluded can opt out by calling 214-648-6726. Those patients will be given a special wristband to alert paramedics that they don't want to participate in the study.
Dr. Paul Pepe, chief of emergency medicine at UT Southwestern and medical director for the BioTel System, emphasizes the lifesaving effect that conducting such studies will have in the community.
"Experience has shown us that survival rates go up significantly in cities that provide this kind of research initiative for their citizens," said Dr. Pepe, who is also a co-investigator in the study. "Given the fact that patients who will be cared for in these studies currently have a grim prognosis, this unprecedented designation and support from the federal government is not only an honor, but a true opportunity to immediately save more lives."
The ultimate success of the Dallas Center for Resuscitation Research, Dr. Idris said, will depend on the interdependent participation of an array of Dallas area health-care institutions and public safety agencies, including more than 30 area hospitals and more than a dozen municipal EMS programs.
Other co-investigators in the study include Dr. Joseph Minei, vice chairman of surgery at UT Southwestern and medical director of the division of surgical services for the Parkland Health & Hospital System; Dr. Ray Fowler, associate professor of emergency medicine at UT Southwestern and operations director for the BioTel System; and Dr. Michael Ramsay, head of the research institute at Baylor University Medical Center.
In addition to Dallas, the other U.S. resuscitation centers will be in Birmingham, Ala.; Iowa City, Iowa; Milwaukee; Portland, Ore.; Seattle and King County, Wash.; Pittsburgh; and San Diego. Toronto and Ottawa also were chosen as resuscitation centers.
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