UC to study new use of drug in patients with traumatic brain injury
CINCINNATI - Researchers from the University of Cincinnati College of Medicine will soon participate in a national clinical trial to determine whether a new use of an existing drug can improve outcomes for patients who have suffered traumatic brain injury (TBI).
The multi-center study will test whether people who have life-threatening or life-altering TBI do better when they receive a medication called tranexamic acid (TXA), which prevents the breakdown of blood clots when given intravenously. It is already used to control bleeding for many conditions, including ruptured aneurysms and hemophilia, and during cardiopulmonary bypass and liver transplantation. Recently, it has been studied by the military for use in trauma patients at risk for hemorrhage and in those with TBI.
Locally, the TXA study will be led by Bryce Robinson, MD, Associate Professor of Surgery at the UC College of Medicine and a trauma surgeon with UC Health. Co-investigators include Jason McMullan, MD, Assistant Professor of Emergency Medicine, and Norberto Andaluz, MD, a Mayfield Clinic neurosurgeon and Director of Neurotrauma at the UC Neuroscience Institute.
The researchers will study whether TXA, when given as soon as possible after injury, improves patients’ mental recovery. Specifically, they will focus on patients transported by UC Health Air Care after a traumatic injury. Because patients with traumatic injury may be unable to give consent to participate in the study, the TXA trial falls under the unique FDA federal regulation concerning “exception from informed consent."
Such regulations are strict, and the research must meet very specific federal regulations and local Institutional Review Board review and approval. These regulations give the researcher the ability to enroll patients into the study when they cannot consent for themselves because of life-threatening injury or illness.
"In the TXA study, medics will use information such as blood pressure, pulse rate, injury type and level of mentation, or mental activity, to determine if a patient with a traumatic brain injury is eligible to take part in the study," Dr. Robinson says. "Enrolled patients will randomly receive one of two combinations of TXA or plain saltwater by the medics and in the hospital."
- Group 1 will receive a one-gram dose of TXA at the scene and a 1 gram dose of TXA in the hospital.
- Group 2 will receive a two-gram dose of TXA at the scene and plain saltwater in the hospital.
- Group 3 will receive plain saltwater at the scene and in the hospital.
"All other treatments will be the same," adds Dr. McMullan. “Participation in the TXA does not affect any other step of the patient’s care, and patients who choose not to participate in this study will receive all of the standard care determined by their physicians."
Study leaders are currently conducting community consultation meetings about the TXA study. To schedule a community consultation meeting or receive more information, contact the study staff at 513-558-6332 or email firstname.lastname@example.org. The TXA study is sponsored by the National Institutes of Health-supported Resuscitation Outcomes Consortium and includes 10 North American Level I trauma centers.
Patients who wish to not be included in the TXA study can request an opt-out bracelet or wallet card that indicates to paramedics that the patient declines to be part of this study.
For more information on the study, or to request an opt-out bracelet, call (513) 558-6332 or email email@example.com.