May 19, 2006
New federally funded research program aims to improve survival from severe trauma
Hypertonic resuscitation — a concentrated intravenous (IV) dose of saline, with or without dextran, a sugar solution — has the potential to help survivors of traumatic injury by improving blood flow and delivery of oxygen to the injured brain while decreasing high pressure in the brain, a common problem for patients with brain injury. This therapy is going to be tested in a research study at 10 hospitals in the U.S. and Canada, including University of Washington (UW) physicians based at Harborview Medical Center, pending UW’s Human Subjects Committee review.
“Trauma is the leading cause of death for Americans between 1 and 44 years of age,” says Dr. Eileen Bulger, a UW associate professor of surgery and investigator for the study at Harborview. “We hope this study helps us learn the best ways to improve survival chances for patients who suffer severe trauma.”
The hypertonic saline study will include patients aged 15 years and older who are being treated for blunt trauma (e.g., injuries caused by car crashes), penetrating trauma (e.g., bullet or stab wounds), and traumatic brain injury.
Care for those who experience trauma begins in the field, with paramedics and flight nurses providing airway management, spinal immobilization and IV fluids. Given to help replace lost blood and support blood flow to vital organs, IV fluids are especially important for patients who have suffered brain injuries. Current pre-hospital treatment includes two liters of an IV saline solution having a similar concentration to human plasma.
The experimental hypertonic saline with dextran (HSD) or without (HS) solution is more concentrated than the current treatment and may offer potential benefits to victims of trauma, including more rapid improvement of blood pressure, improved blood flow to the injured brain while decreasing the high pressure in the brain, and an altered immune system response which may decrease the risk of infection and acute respiratory distress syndrome.
HSD is already approved for use in 14 countries, including the United Kingdom, France, Germany, Sweden, Norway and Denmark. It has been the subject of eight previous clinical trials in the U.S., all of which showed improved survival with HSD, but these studies had an insufficient number of subjects or involved patients with primarily penetrating trauma.
There will be approximately 400 patients enrolled from our region. One-third will receive traditional resuscitation, one-third will receive HS, and one-third will receive HSD. All other aspects of medical and surgical care will be the same for all of the groups.
Because HSD/HS must be immediately given after injury, it is not possible to obtain informed consent from patients, or their family members. All participants (or family members) will be asked to give their informed consent to continue in the study once it is possible to do so. A recently completed community survey of residents from King County and the surrounding region suggest support for the study with 77 percent of respondents indicating that they would consent to receive the study fluid if injured and 71 percent believe it is appropriate to include 15 — 18 year old patients. The Food and Drug Administration has given the researchers permission to do this study and enroll patients without their consent due to the emergency nature of their illness and the potential benefit of this treatment. The UW’s Human Subjects Review Committee is currently reviewing the research proposal and the study will not start until it is approved by the committee.
Potential side effects of HSD and HS include possible allergic reaction to dextran, seizures due to very high salt levels in the blood, and rapid increase in blood pressure leading to more bleeding. None of these side effects have been seen in previous clinical trials.
The study is being funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH), the lead federal sponsor of the research effort. Other funding agencies include the U.S. Department of Defense; the NIH’s National Institute of Neurological Disorders and Stroke; the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research; Defence Research and Development Canada; the Heart and Stroke Foundation of Canada; and the American Heart Association.
Harborview Medical Center and the University of Washington welcome public comment on the Hypertonic Saline study. Further information can be found on the study’s web site: http://www.uwmedicine.org/Facilities/Harborview/Overview/Research/HypertonicSaline/index.htm or by leaving a message at 1-800-607-1879 or 206-341-4721.