BIRMINGHAM, Ala. – The UAB Institutional Review Board (IRB) is hosting a community meeting on March 20 to solicit public opinion and feedback on proposed studies that seek to improve the current treatment for trauma patients by local emergency medical service (EMS) responders.
The meeting will be held at 6 p.m. at Vestavia Hills United Methodist Church’s Tyson Hall, 2061 Kentucky Ave. Questions or concerns about the proposed study may be answered by contacting Jeffrey Kerby, M.D., at 205-934-9532 or going to www.uab.edu/arc. Questions about the rights of a potential research participant may be addressed to Sheila Moore at 205-934-3789 or irb@uab.edu.
UAB is one of 10 centers in the United States and Canada that seek to conduct clinical trials for cardiac arrest and life-threatening trauma. Traumatic injury is the leading cause of death in the United States between the ages of 1 and 44 years. Alabama has one of the highest traumatic injury death rates per capita in the nation. Half of these deaths occur before the patient reaches an emergency department.
The majority of patients who meet the enrollment criteria for this type of research are expected to either be unconscious or have an altered mental status and be unable to properly consent to be enrolled a study. Strict Food and Drug Administration guidelines allow for patients in life-threatening situations to participate in research without standard informed consent. Patients and/or family will be notified of their participation as soon as feasible and consent will be sought for ongoing study participation.
In the initial study by the UAB Emergency Medicine and Surgery departments, patients with injuries and either a low blood pressure or with an altered mental state will receive an intravenous infusion of either one cup of normal saline (water with the saltiness of the blood, which is the current standard of care), hypertonic saline (more concentrated salt water), or hypertonic saline with dextran (more concentrated salt water with a sugar molecule added).
Potential benefits of hypertonic resuscitation include: compensating for blood loss more effectively with more rapid improvement of blood pressure, improved blood flow to the brain while at the same time decreasing pressure in the injured brain and lessening the inflammatory response, which may decrease the risk of infection and organ injury.
Hypertonic saline has been studied extensively in Europe and has been tested in the US in more than 500 patients in eight clinical trials without reports of life-threatening adverse effects. Possible adverse effects that this study will monitor include: increased sodium (salt) levels that could contribute to seizures requiring medical treatment, the potential for the blood not to clot as well as usual which might cause increased bleeding, skin irritation at the site of the infusion or a rash due to a minor allergic reaction.
The IRB’s mission is to ensure that research involving human participants is conducted in an ethical manner. This includes ensuring that risks to participants are minimized, the selection of participants is made without regard to ethnicity, race or gender, and participants are fully informed of what their participation will entail and of the potential risks and benefits.