Irvine, Calif., July 8, 2008 — A method of resuscitation for victims of severe traumatic injury will be the subject of a clinical trial to be undertaken by a team of Orange County emergency care providers.
The Orange County Resuscitation Outcomes Consortium will include UC Irvine, Orange County Health Care Agency, Mission Hospital, Western Medical Center Santa Ana, Orange County Fire Authority, and fire departments from other Orange County cities.
The ROC group will conduct and oversee a clinical effort in which people who receive severe traumatic injury – such as in a serious motor vehicle accident – will be treated with hypertonic saline solution as part of the emergency medical response. Previous studies have shown that hypertonic saline safely and effectively decreases inflammation, especially with brain trauma, and that survival outcomes potentially can improve.
Orange County ROC is part of a National Institutes of Health federally funded study involving emergency medical services agencies, public safety agencies, regional hospitals, community healthcare institutions and medical centers in 11 regions in the United States and Canada, and as many as 15,000 patients over a three-year period. The overall goal is to learn the best ways to improve survival from cardiac arrest and severe trauma. Orange County will participate only in the trauma portion of the study.
"Clinical research has made great advances in medical care over the past quarter century, but there have been few similar advances in the area of emergency response care. The ROC study represents the greatest effort yet to make advances in this area and help save the lives of the thousands of Americans each year who otherwise would die from their traumatic injuries," said Dr. David Hoyt, the John E. Connolly, M.D., Chair of Surgery at UC Irvine Medical Center and Orange County ROC study leader. Hoyt, one of the nation's top trauma surgeons, leads the ROC trauma trials at the national level.
The trial is especially important, Hoyt added, because unintended accidents are the fourth leading cause of death in the United States, according to the National Center for Health Statistics. Nearly 43,000 Americans die each year in motor vehicle traffic accidents alone.
"The ROC study is essential to help determine how these new treatments can be used to save more lives," said Dr. Ken Miller, Orange County Fire Authority medical director. "Because these interventions are time sensitive, they will be initiated by paramedics trained in the study protocol and be further evaluated during in-hospital patient treatment and recovery."
The Orange County ROC trial will differ from other clinical trials because many of its participants will not be able to give consent or have family nearby to do so. Consent is required for all clinical studies, although federal law allows for exceptions if the safety of the product to be used has been proven in previous trials and if study leaders conduct community outreach discussions and opt-out measures for those who do not want to participate.
To introduce the study, the Orange County ROC will hold community outreach meetings. The confirmed scheduled includes:
- 6 p.m. Wednesday, July 16, at the Laguna Hills Community Room in Laguna Hills.
- 6 p.m. Monday, July 28, at the Fullerton Public Library in Fullerton.
- 6 p.m. Wednesday, July 30, at the Santa Ana Public Library in Santa Ana (Spanish).
- 2 p.m. Sunday, Aug. 10, at the Korean Presbyterian Church in Westminster (Korean).
For detailed meeting information, visit www.healthcare.uci.edu/roc.asp.
The Orange County ROC study has been reviewed and approved by Institutional Review Boards at Western Medical Center Santa Ana, Mission Hospital, the Orange County Health Care Agency and Children's Hospital of Orange County. UC Irvine's Institutional Review Board has granted conditional approval dependent upon community consultation and feedback.
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