OHSU Proceed With Study to Improve Survival From Traumatic Injuries
10/16/06 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 has received approval to move forward with a study that aims to determine whether a different type of resuscitation fluid than normal saline can improve survival rates in severely injured people. The study is the first as part of OHSU's partnership in the National Institutes of Health-funded Resuscitation Outcomes Consortium (ROC).
ROC is a group of 11 regional medical centers across the United States and Canada seeking 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 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). This study will determine whether hypertonic saline (water containing more salt than blood) or hypertonic saline with dextran (an added sugar molecule) improves survival or brain function recovery. It is believed that hypertonic saline will allow blood flow to be restored with a smaller amount of fluid than regular saline, thereby reducing overexpansion of blood vessels and reducing inflammation following injury.
The individuals eligible for this study will be severely injured, and therefore unable to provide informed consent. Because of this, the study will be conducted under Food and Drug Administration (FDA) regulations that allow research of emergency treatments in certain life-threatening situations without the patient's pretreatment consent.
As part of the FDA regulations allowing exception to informed consent studies, OHSU was required to conduct a campaign to notify and consult with the community about the study. That campaign included random phone surveys, public meetings in each of the four participating counties, ads in local newspapers, letters sent to neighborhood associations and elected officials, a news release to local media that generated news coverage, and presentations at meetings of minority and other community organizations.
The study was reviewed and approved by an independent panel of scientists chosen by the NIH, but not participating in the study design. The FDA approved the study and will continue to monitor the study for safety purposes. Locally, groups called Institutional Review Boards (IRBs) are required to review and approve these studies following the community consultation campaign. IRBs of OHSU, Legacy Emanuel Hospital, Southwest Washington Medical Center and Multnomah County and Oregon State Public Health all reviewed and approved the hypertonic saline study.
"We undertake this study after intense local and national review. The results of the study will likely guide the future choice of resuscitation fluid to be used by paramedics across all of North America," said Jerris Hedges, M.D., principal investigator, Greater Portland ROC site, 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 due to head injury. OHSU expects most eligible subjects to be injured as a result of motor vehicle crashes. Women who are obviously pregnant, children 14 and under, and individuals under arrest at the time of the incident will not be enrolled.
Following a traumatic injury, emergency medical services personnel (paramedics) will arrive on the scene and determine whether the individuals involved meet the criteria for the hypertonic saline study. If they do, paramedics will start an intravenous (IV) delivery of a resuscitation fluid. Paramedics will not know whether they are providing regular saline, hypertonic saline or hypertonic saline with dextran. All bags will be bar-coded and scanned so it can be determined later whether the individual received one of the study solutions. If the patient needs more fluid before arriving at the hospital, paramedics will provide additional regular saline. No one will receive more than one small bag (about one cup) of hypertonic saline. Subjects enrolled in the study, and their family members, will be informed of their participation as soon as possible.
"We are dedicated to finding the best ways for our local paramedics to treat emergencies, and the only way to do this is to actually test experimental procedures in the field. Only then can we determine the best procedures," said Hedges.
Any community member who does not want to be included in this hypertonic saline study, or in future ROC studies that are carried out without individual advanced informed consent, can obtain a bracelet that gives them the choice to opt out of all such studies.
The bracelet will resemble a medical alert bracelet, and paramedics in the four participating counties will be trained to look for them and exclude any person, wearing this bracelet, from the study. To obtain a bracelet, call OHSU study coordinator Denise Griffiths at 503 494-7015.
More information about the Resuscitation Outcomes Consortium and the hypertonic saline study can be found at www.ohsu.edu/emergency/roc