Studies aim to improve outcomes for trauma critical care patients
Can a hormone decrease the brain damage caused by a blow to the head? Is there a better way to treat people with life-threatening seizures? Answers to these questions could provide hope to millions of Americans who suffer these medical emergencies every year.
The Medical Center’s Department of Emergency Medicine is one of many centers nationwide participating in two encouraging clinical trials investigating these questions. “RAMPART and ProTECT are two examples of hypothesis-designed trials that will change medical practice if benefit is shown,” says Thomas Terndrup, M.D., ’81, chair, Department of Emergency Medicine.
Because animal studies have shown that the hormone progesterone reduces swelling and recovery time in brain injury, researchers now hope to harness this therapy for victims of head injuries. “Right now we don’t have an intervention or medication that improves the outcome for traumatic brain injury,” Terndrup says. “And this is a very serious problem in the world, especially for younger individuals, because it affects their entire life if they don’t successfully recover, and a lot of them do not.”
In December 2010, the Emergency Department began enrolling participants in ProTECT (Progesterone for Traumatic brain injury Experimental Clinical Treatment), a four-year trial that will determine whether a progesterone infusion given within four hours of blunt head trauma will have a significant protective effect and give patients a chance at the quickest recovery times. Since this is a randomized study, patients at the Medical Center will either receive standard care plus progesterone therapy or standard care and placebo. Researchers hope to enroll thirty-six patients.
On another front, the Emergency Department along with Life Lion Emergency Medical Services, in the past year completed participation in a study investigating a new method for delivering anti-convulsant medication. Seizures that don’t stop within five minutes can be fatal if not treated quickly. Therefore, the aim of RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial) is to find out whether anti-seizure medications given as a shot in the muscle are just as effective as anti-seizure medications given by intravenous injection. Currently, first responders give the medication intravenously, but that can take time and delay treatment.
These studies operate under the FDA regulation called exception from informed consent (EFIC), which means paramedics and doctors are able to enroll patients in the trial when they cannot speak for themselves due to their illness or injury. In these studies, research must meet local institutional review board approval and community members can choose to opt out. Information about the trials, results or how to decline is available on the website of the Department of Emergency Medicine.
“The ultimate goal of the studies is the discovery of better treatments. Research innovation and improving care is what we are all about,” Terndrup says. “These studies and others will enable us to define better standards of care for patients with traumatic brain injury, seizure disorders, sepsis care, and more. Additionally, our participation means our central Pennsylvania population will be included in the efficacy results.”
– By Paula Rasich