OHSU leads study to improve recovery from traumatic brain injury
10/06/14 Portland, Ore.
Oregon Health & Science University is one of 10 trauma centers in North America to study whether people who sustain a traumatic brain injury have better outcomes when given an FDA-approved drug called Tranexamic Acid, or TXA, before they reach the hospital.
“Our goal is to stop the bleeding sooner. By preventing further brain injury, we hope to improve mental recovery,” said Susan Rowell, M.D., M.C.R., principal investigator for the Oregon study and Associate Professor of surgery (trauma, critical care and acute care surgery) in the OHSU School of Medicine.
To conduct this research, paramedics, first to arrive on the scene, will assess whether an individual has a traumatic brain injury that meets study criteria. Those who qualify will be randomly assigned to one of three study groups:
- Group 1 will receive a gram of TXA at the scene and a gram of TXA in the hospital.
- Group 2 will receive 2 grams of TXA at the scene and plain salt water in the hospital.
- Group 3 will receive plain salt water at the scene and in the hospital.
“All of these are the standard doses used for bleeding after trauma,” explained Rowell.
OHSU expects to enroll approximately 100 people and follow them for six months after discharge.
Because patients eligible for the study will be unconscious and, therefore, unable to provide consent prior to treatment, the study will be conducted under the FDA’s Exception from Informed Consent regulations, which allow research in certain life-threatening situations without prior authorization.
These studies require community consultation and notification to ensure the public is aware.
Individuals who do not want to be enrolled in the study can decline participation by “opting out” or wearing a “NO STUDY” bracelet. To request a bracelet, call 503-494-2183 or email email@example.com. Those who choose not to participate in the study will receive all of the standard care as determined by their physicians.
Emergency medical service agencies participating in the study include Multnomah American Medical Response and Clackamas County American Medical Response.
This multi-center study is part of the National Institutes of Health-funded Resuscitation Outcomes Consortium, or ROC, a group of regional health centers across the United States and Canada conducting clinical trials in and out of the hospital to improve outcomes in patients with severe traumatic injury and cardiac arrest.
The research is funded by a grant from the National Institutes of Health (5U01HL077863) and the Department of Defense DOD (ERMS#13335004).
Oregon Health & Science University is the state's only public academic health and research university. As one of Oregon's largest employers with more than 14,000 employees, OHSU's size contributes to its ability to provide many services and community support not found anywhere else in the state. OHSU serves patients from every corner of Oregon and is a conduit for learning for more than 4,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to each county in the state.