ROC - TXA

Tranexamic Acid for Traumatic Brain Injury

Overview

Oregon Health & Science University 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.

The study will be conducted at 10 Level 1 trauma centers in North America including OHSU. The research 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.

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

  • Group 1 will receive 1 gram dose of TXA by the medics and one gram dose of TXA in the hospital
  • Group 2 will receive 2 gram dose of TXA by the medics and plain salt water in the hospital
  • Group 3 will receive plain salt water by the medics 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.

Consent Information

Normally, before someone joins a research study, it is discussed with him or her in detail. Also, a consent form that lists the purposes of the study, the possible benefits, and the risks from being in the study is reviewed with the person. If the person agrees to join the study, the consent form is signed. In most cases, this takes place before any study procedures are done or treatment is given. This process is called "informed consent" and ensures that the person volunteered for the research study only after being given the information necessary to make an informed decision.

For this study, investigators will not be able to get written informed consent from each study participant, due to them having a life threatening or life altering traumatic brain injury. Instead, the investigators will try to inform the community about the study and address any concerns or questions before the study is approved to begin. We will do this by:

  • This website
  • Community meetings
  • Online and mailed surveys
  • Newspapers and Newsletters

People will be given the choice to refuse being in the study by contacting the investigators at OHSU and asking to opt-out.

Contact Us

If you still have questions after reviewing the website, please contact us via e-mail at roc@ohsu.edu. (Note that the confidentiality of e-mail communications cannot be guaranteed) or at (503) 494-8083 where you will be able to leave a voice message. The e-mail and voice mails are checked regularly and you can expect to receive a reply within 3 days.

News

May 26th, 2015 - The Tranexamic Acid (TXA) study is now underway in Multnomah and Clackamas Counties.