OHSU Seeks Community Input on Study to Improve Survival from Traumatic Injuries
05/01/06 Portland, Ore.
Study is part of a national consortium to find the best methods for resuscitation outcomes at the site of injury
Oregon Health & Science University is part of the National Institutes of Health- funded Resuscitation Outcomes Consortium (ROC). This group of 11 regional medical centers across the United States and Canada seeks to find promising scientific and clinical advances to improve survival from cardiac arrest and severe trauma.
The ROC will consist of multiple studies during the course of several years, testing new or alternative drugs, tools and techniques. OHSU will work directly with emergency medial services (EMS) agencies and hospitals in Multnomah, Clackamas, Washington and Clark counties to conduct this important research.
The current standard of care for treating people with traumatic injuries in the field is to intravenously administer saline (water with the same salt content as blood). The first ROC study will determine whether hypertonic saline (water containing more salt than blood) or hypertonic saline with dextran (an added sugar molecule) will improve survival or brain function recovery. It is believed hypertonic saline will allow blood flow to be restored with a smaller amount of fluid than regular saline, which will avoid overcrowding blood vessels and reduce inflammation following injury.
Because individuals eligible for this study will be unable to provide informed consent due to the nature of their injuries, the study will be conducted under Food and Drug Administration regulations that allow research in certain life-threatening situations without authorization. The federal regulations that allow this waiver of consent require community notification to ensure the public is aware of the study. To that end, OHSU will hold four community meetings, one in each county where the study will take place, to offer the public a chance to ask questions and share their opinions about the study. (See meeting dates at the end of the release.)
"We are dedicated to finding the best ways to handle medical emergencies, and the only way to do this is to actually try experimental procedures in the field. Only then will we know what the best procedures are," said Jerris Hedges, M.D., OHSU's principal investigator, professor of emergency medicine and vice-dean in the OHSU School of Medicine.
To be eligible for the study, subjects must have severe injuries with either low blood pressure or an altered mental state. OHSU expects most eligible subjects to be involved in motor vehicle accidents. Women with an obvious pregnancy and individuals under arrest at the time of the accident will not be enrolled.
Following a traumatic accident, EMS will arrive on the scene and determine whether the individuals involved meet the criteria for the hypertonic saline study. If they do, EMS will start an intravenous (IV) delivery of saline. EMS agents will not know whether they are providing regular saline or hypertonic saline. All bags will be bar-coded and scanned so it can be determined later whether the individual received the study solution. If the patient needs more fluid before arriving at the hospital, EMS agents will provide regular saline. No one will receive more than one bag (equal to one cup) of hypertonic saline. Subjects enrolled in the study, and their family members, will be informed of their participation as soon as possible.
"Patient safety is our highest concern. All study protocols will be reviewed before implementation by an independent panel of scientists chosen by the NIH, but not participating in the study design. Each community also will perform its customary review of the study protocols before implementation," said Mohamud Daya, M.D., OHSU study investigator and associate professor of emergency medicine in the OHSU School of Medicine. "Finally, a second independent panel of scientists (Data and Safety Monitoring Board) will monitor each trial for safety purposes."
Recent studies of hypertonic saline and hypertonic saline with dextran done in Australia, Canada and the United States have shown no adverse reactions from the treatment, but have all been too small to draw definitive conclusions. The group of medical centers working together as part of the ROC will allow more people to be studied across rural and urban settings. The ROC will provide the necessary infrastructure to conduct multiple collaborative trials to aid rapid translation of promising scientific and clinical advances to improve resuscitation outcomes.
The sooner treatment can be provided following an accident, the better the rate of survival. The ROC will allow EMS providers to study proposed new treatments for traumatic injuries at the scene of an accident, where people are most likely to benefit from them. OHSU hopes to begin enrolling patients in the hypertonic saline study this summer.
The community meetings will be held:
Monday, May 8, 7 p.m. at the Southwest Washington Medical Center Health Education Center, 600 N.E 92nd Ave., Vancouver, Wash.
Tuesday, May 9, 7 p.m. at the Washington County Public Services Building Auditorium, 155 N. First Ave., Hillsboro
Wednesday, May 10, 7 p.m. at the OHSU Auditorium (old library building), 3181 S.W. Sam Jackson Park Road, Portland
Monday, May 15, 7 p.m., at the Clackamas County Fire District #1 Oak Lodge Station 3, 2930 S.E. Oak Grove Blvd., Milwaukie
The community may learn more information about the ROC and the hypertonic saline study by visiting www.ohsu.edu/emergency/roc where they are encouraged to fill out a short survey, or by calling study coordinator Denise Griffiths at 503 494-7015 or 888 370-2888.