TXA for TBI
Pre-Hospital Administration of Tranexamic Acid for Traumatic Brain Injury
Susan Rowell, M.D., M.C.R.
What is the TXA for TBI study?
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. To conduct this research, paramedics, who are the 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. OHSU expects to enroll approximately 100 people and follow them for six months after discharge.
Why do this study?
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.
Who will be included?
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 503-494-4315 or email firstname.lastname@example.org. Those who choose not to participate in the study will receive all of the standard care as determined by their physicians.
For more information contact Research Manager Samantha Underwood, MS, CCRP