June 30, 2003 Hypertonic resuscitation – a concentrated intravenous (IV) dose of saline and dextran, a sugar solution – has the potential to help survivors of blunt trauma 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 now being tested in a research study by University of Washington (UW) physicians based at Harborview Medical Center.
“Trauma is the leading cause of death for Americans between 1 and 44 years of age,” says Dr. Eileen Bulger, a UW assistant professor of surgery and principal investigator for the study. “Of the trauma patients we treat at Harborview, 80 percent are victims of blunt trauma - drivers and passengers in motor vehicle crashes, injured motorcyclists, pedestrians and bicyclists struck by cars, and victims of falls and assaults with blunt objects.”
Trauma care begins in the field, Bulger explains, 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 trauma 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/dextran (HSD) solution is more concentrated than the current treatment and may offer potential benefits to victims of blunt trauma, Bulger says, 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.
The Harborview study, which is funded by the National Institute of Health, will enroll 400 patients. Half will receive traditional resuscitation and half will receive HSD. All other aspects of medical and surgical care will be the same for both groups.
Because HSD must be administered shortly after injury, it will be difficult to obtain informed consent from patients, who may be unconscious, or their family members. The Food and Drug Administration and the UW’s Human Subjects Review Committee has given the researchers permission to do this study and enroll patients without their consent due to the emergency nature of their illness. 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 75% of respondents indicating that they would consent to receive the study fluid if injured and 77% agreeing that the waiver of informed consent is justified.
Potential side effects of HSD include possible allergic reaction to dextran, seizures due to very high salt levels in the blood, an rapid increase in blood pressure leading to more bleeding. None of these side effects have been seen in previous clinical trials.
Harborview Medical Center and the University of Washington welcome public comment on the HSD study. Further information can be found on the study’s web site: http://www.washington.edu/medicine/hmc/overview/studies/esd.html or by leaving a message at 1-800-506-1309 or 206-341-4721.
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