With the hope of improving the survival rates of patients with severe injuries and brain damage, a new study at Oregon Health and Sciences University (OHSU) will test a saline solution with higher salt content on thousands of patients in several counties around Oregon.
Saline solution presently contains about as much salt as human blood and is commonly used to treat rapid blood loss, help maintain blood pressure and compensate for fluid loss in ambulance patients. Hypertonic saline, which contains more salt than human blood, may help reduce brain swelling and prevent inflammation. It is also thought that the solution may help patients recover more efficiently.
”The saltier solution would reduce time in intensive care," said Jerris Hedges, professor of emergency medicine at OHSU and the principal investigator for the clinical trial.
Due to the delicate state of severely injured patients, the experimental solution will be administered without the patients’ “informed consent." OHSU must perform the procedures under specific Food and Drug Administration regulations because of patients’ inability to give their informed consent.
As part of these regulations, OHSU was required to communicate with and consult the communities that could be involved in the clinical trial. The State of Oregon Public Health Division and other Oregon county review boards have all approved the trial.
Hedges said he believes that the study will yield positive benefits. Because the hypertonic saline solution has a higher salt concentration than common saline solution, it will cause the blood vessels to expand and keep the solution in the veins longer, preventing rapid loss of water, restoring blood pressure, and reducing the swelling that can result from brain injury.
Hedges said he feels that this is a particularly important issue for young “college-aged" individuals because there is a disproportionate number of young people who receive severe injuries. The mobility of young people today, Hedges said, increases their risk of injury since accidents involving automobiles are common.
According to information from OHSU, severe injury is the number one cause of death in children and adults under the age of 44. It is estimated that 175,000 people die from brain injury, loss of blood and organ failure each year in North America. Fifty percent of patients who die from severe injuries die on site, while 30 percent die within two days and 20 percent die after a long stay in intensive care.
Starting in early November, victims of severe injury and trauma in Multnomah, Washington, Clark and Clackamas counties will take part in the clinical trial.
A second experimental solution, called hypertonic saline with dextran, contains an added sugar molecule, but it remains to be determined whether the sugar molecule makes a difference, according to OHSU.
According to research by OHSU, eligible candidates for the trial will be those who are severely injured and have low blood pressure from blood loss, or head injuries that may affect their mental state. After the patients’ eligibility for the study is confirmed, the paramedics will administer the experimental solutions intravenously, and they will not know which solution they are using.
The bags will be labeled with a barcode, which will be scanned later at the hospital to determine if a test solution was used. Patients will not be given more than one bag of unknown solution. If more bags are required before reaching the hospital, only regular saline will be used.
According to Hedges, there are some possible side effects to the use of these new solutions, but since test patients will be closely monitored once they reach the hospital, the effects are unlikely.
The side effects could include seizures caused by high sodium levels in the body as a result of the higher salt content of the solution, but Hedges says that studies to date have shown this to be unlikely.
Another possible side effect is an allergic reaction to the dextran, but Hedges said this would only happen if the patient received multiple doses of the solution with dextran.
OHSU is instituting the clinical trial in partnership with the Resuscitation Outcomes Consortium (ROC). The ROC is a group of medical institutions from the United States and Canada that work closely with paramedics to investigate improvements in the treatment of severe trauma and cardiac arrest. Over many years, the ROC will test a variety of new treatment methods (medicines, tools, techniques) to determine which will provide the best outcome.
According to Gary Oxman, Multnomah County health officer and primary reviewer of the trial for the Multnomah County review board, the trial was approved after a series of steps. First, the study was reviewed for scientific value, to determine whether it was valuable to the community. The committee then reviewed the procedures of the study and what was known about its risks and benefits. If the study was not ethically sound, or held too much risk for the community, Oxman said it would not have been approved.
A number of community meetings were held by Oxman and the committee concerning the trial but had poor attendance, according to Oxman. Although the meetings were not well attended, favorable results were found through telephone surveys and surveys of those that did attend the meetings. According to Oxman, 70 to 75 percent of the individuals surveyed said they thought the study was reasonable and that they would be willing to participate.
For those that are not willing to participate in the trial, or in any future trial in which consent is waived, an opt-out bracelet can be obtained from OHSU by calling 503-494-7015. The bracelet resembles a medical alert bracelet and must be worn at the time the paramedics arrive to ensure that a test solution is not used.