A multi-site efficacy drug study is currently underway to test the reliability of tranexamic acid (TXA) on patients with potentially life-threatening or altering traumatic brain injury (TBI). TXA is an effective hemostatic agent, commonly used in various surgical procedures to prevent excessive blood loss. At the moment, the study’s leaders are working on community consultations to determine support for this research.
Lead investigator in Houston, Dr. Bryan Cotton, is a professor at the Department of Surgery at the University of Texas Health Science Center (UTHealth) Medical School. He and his team will evaluate the potential benefits of administering TXA immediately in the event of a TBI, and whether it leads to improved mental recovery. Participating in this study are several Level 1 trauma care centers in the US, including Memorial Hermann-Texas Medical Center.
Future findings from this study will significantly impact how first-on-the-scene medics administer emergency treatment to victims of a TBI. This research will necessitate participating centers’ medics to assess the patient’s vital signs, injury, and mental activity to identify possible study participants. Subsequent treatments will be uniform, and TBI patients who do not wish to participate will not receive treatment that is any different from the facility’s standard protocol for TBI. Those who qualify and consent will either receive TXA or a placebo immediately from the medics, followed by another dose of either of the two at the hospital:
- Group 1 participants will receive 1 gram of TXA upon contact with medics, followed by another gram upon arrival at the hospital.
- Group 2 will receive 2 grams of TXA upon contact with medics, followed by a placebo upon arrival at the hospital.
- Group 3, the control group, will receive a placebo at both instances.
The researchers are aware this study will involve the eliciting of consent from parties who are likely to be unconscious, or unfit to give well-informed consent, so as a result, the Committee for the Protection of Human Subjects will be exempting this study as it is classified as emergency research. Attending medics will have the authority to enroll TBI patients unable to give consent.
Those not interested in taking part in this study may contact Laura Vincent through Laura.E.Vincent@uth.tmc.edu or (713) 500-5216 to request for an “opt out” wristband or identification card, which will ensure the wearer will not be enrolled in the study.