The University of Texas Health Science Center at Houston (UTHealth) is part of a multi-site study testing if people who have life-threatening or life-altering traumatic brain injury (TBI) fare better when they receive a medication called tranexamic acid (TXA). Dr. Bryan Cotton, professor in the Department of Surgery, is the principal investigator for the Houston site testing TXA, which is used to control bleeding in the body.
Study leaders are conducting community consultations to determine if there is support for the research. If the study proceeds as planned, Cotton and his team will look at the results of the study to determine if the study medication, TXA, given as soon as possible after injury, improves the mental recovery after TBI. The study includes multiple Level 1 trauma centers in North America, including Memorial Hermann-Texas Medical Center.
Medics are often the first on the scene after a traumatic event. When medics suspect accident victims have TBI, they will use information such as blood pressure, pulse, injury type, and level of mental activity to determine 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 a placebo, which is normal saline (plain salt water).
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 normal saline in the hospital.
Group 3 will get normal saline by the medics and in the hospital.
All other treatments will be the same. Patients who choose not to participate in this study will receive the standard care as determined by their physicians.
Because this study would 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 Committee for the Protection of Human Subjects, which oversees clinical studies, has granted the study an exception from consent for emergency research, allowing the medics to enroll the patient.
Anyone who does not wish to be involved in this study can contact research nurse Laura Vincent at 713.500.5216 and request an “opt out” wristband or identification card. This wristband or ID card will ensure that the wearer or owner will not be enrolled in this study if this information is available to the EMS upon their arrival at the scene.
To schedule a community consultation meeting, or for more information, contact Vincent.
-Rob Cahill, Office of Public Affairs, Media Relations