We think of emergency rooms as the go-to place for something serious and sudden. But hospitals that also have a certified and staffed trauma center can provide next-level care for life-threatening injuries.
Borne out of battlefield medicine, trauma medicine aims to bring optimal, multidisciplinary care to someone who has suffered a severe injury, such as a gunshot wound or the impact of a car crash. And the trauma center team must deliver this care quickly.
“Trauma centers offer more extensive care than emergency departments, and the difference between a trauma center and emergency room can be life and death,” according to the University of Pittsburgh Medical Center (UPMC) whose system operates several trauma centers.
“Hemorrhage is the most common reason why people die early on after their injury – and it is potentially preventable,” said Dr. Brahm Goldstein, Vice President, Research and Development, Hematology at CSL Behring, a global biotech leader in plasma-derived and recombinant therapies.
Goldstein is working on CSL Behring’s forthcoming clinical trial in trauma medicine, which will study whether a concentrate of key blood components (4-Factor Prothrombin Complex Concentrate, 4F-PCC) could be useful in stopping dangerous bleeding in trauma patients.
At trauma centers, you’ll find highly trained clinicians who specialize in treating traumatic injuries, including trauma surgeons, neurosurgeons, orthopedic surgeons, cardiac surgeons, radiologists and registered nurses.
“They staff the center 24/7 and have access to resources such as an operating room, resuscitation area, laboratory, and diagnostic testing equipment. They are always prepared to treat patients,” according to UPMC.
Trauma centers are found all over the world and are categorized by different levels by the American Trauma Society based on its resources and the number of trauma patients admitted each year. There are five levels of trauma centers: I, II, III, IV, and V. CSL Behring’s planned trauma trial will occur at the highest levels of care, Level I or II centers, in the U.S., or the equivalent elsewhere.
The need is great for innovation and advances that can help trauma patients, Goldstein said, but conducting clinical trials can be challenging for obvious reasons. Patients don’t enroll in the typical way by getting a lot of information in advance and then giving their consent. No one plans to be a trauma patient. There isn’t time to ask for consent in the usual way when someone’s injuries are life-threatening and patients are in no condition to understand the trial and provide informed consent.
The need to conduct clinical trials in patients with emergency life-threatening conditions was recognized many years ago by the U.S. Food and Drug Administration and other regulatory bodies in other countries. The planned trial will operate under an exemption from informed consent (EFIC).
“In the past 15 years, EFIC has enabled trauma investigators to conduct trials immediately when patients arrive in the trauma center and has resulted in marked improvements in trauma care,” Goldstein said. “Yet there is still a huge need to continue to improve trauma care and reduce early mortality.”
Sites that want to conduct a clinical trial at a trauma center take pains to inform the community of the upcoming research and give members of the general public the opportunity to opt out, he said. The outreach often occurs using social media and church communities. After the public notice requirement is met, if someone is injured and meets the criteria to be included, they could be enrolled in the trial, which means that, in addition to standard trauma resuscitation care, they would receive the trial treatment or a placebo to determine if the trial treatment can improve survival.
