UC to Study New Drug in Patients with Traumatic Brain Injury

I'm sure this is a patentable drug so someone is going to make a lot of money off it. 1.4 million TBIs a year in the US and millions more concussions. Why not try fish oil?
http://healthnews.uc.edu/news/?%2F24670%2F
Researchers from the University of Cincinnati’s Department of Surgery, Division of  Trauma and Critical Care and the Department of Emergency Medicine will soon participate in a national clinical trial to determine if a new therapy can improve outcomes for patients with 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 is used to stabilize bleeding.

When given intravenously, TXA prevents the breakdown of blood clots. 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, an associate professor of surgery at the UC College of Medicine and a trauma surgeon with UC Health.

Working with Jason McMullan, MD, assistant professor of emergency medicine and UC Health emergency medicine physician, Robinson and collaborators 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,” says Robinson. "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 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 txa@uc.edu.

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 txa@uc.edu.