Public notification: Study using a medication to improve the mental status of people with traumatic brain injury

by Hennepin Healthcare

Hennepin County Medical Center (HCMC) is part of a multi-site study testing whether people who have life-threatening or life-altering traumatic brain injury do better when they receive a medication called Tranexamic Acid (TXA) that is used to stabilize bleeding in the body. Dr. Paul Nystrom is the principal investigator for this clinical study.

The study will be conducted at 12 Level 1 trauma centers in North America including HCMC. Dr. Nystrom and his team will look at the results to determine if the study medication, TXA, given as soon as possible after injury improves the mental recovery after traumatic brain injury.

Paramedics are the first people on the scene after a traumatic event. When they suspect that the accident victims (patients) have a traumatic brain injury, they will use information such as blood pressure, pulse, injury type, and cognitive level to tell them if a patient is eligible to take part in the study. Patients enrolled in this study will randomly get one of two combinations of TXA or placebo (plain salt water) by the medics and in the hospital.

Group 1 will get a one gram dose of TXA by the medics and a one gram dose of TXA in the hospital; Group 2 will receive a two gram dose of TXA by the medics and plain salt water in the hospital; and Group 3 will get plain salt water by the paramedics and in the hospital.

All other treatments will be the same. Patients who chose not to participate in this study will receive all of the standard care determined by their physicians.

Because this study will be conducted on people who have suffered trauma and are unlikely to be conscious, permission (informed consent) to take part in this study is not likely to be obtained before the patient is enrolled. Because of this, the Human Subjects Research Committee of HCMC that oversees all clinical studies has granted the study an exception from consent for emergency research allowing the medics to enroll the patient without prior consent. Study leaders will be conducting community consultation meetings to determine if the community is supportive of the research.

Anyone who does not wish to be involved in this study can contact the study staff at 612-873-9528 and ask for the opt-out wristband. This wristband will indicate that that the wearer does not want to be enrolled into this study to the EMS upon their arrival at the scene.

If you would like to schedule a community consultation meeting or would like more information, please contact the study staff at 612-873-9528.