Clot drug tested with suspected brain injuries
[See related Q&A with Dr. Eileen Bulger from July 28.]
Researchers at Harborview Medical Center are taking part in a national study to determine what role tranexamic acid plays in decreasing mortality for trauma victims with suspected brain injuries.
Tranexamic acid, a drug approved by the U.S. Food and Drug Administration, is commonly used to prevent excessive blood loss, for instance, before surgery with hemophilic patients and for women with heavy menstrual bleeding. The drug blocks the natural disintegration of blood clots.
The study is the first to examine the use of tranexamic acid in patients with head trauma. More than 50,000 people in the United States die annually from traumatic brain injury, which is the leading cause of death among trauma patients. The researchers hope this study will shed light on whether a dose of tranexamic acid administered by first responders could reduce that statistic.
“Many patients with severe brain injury have bleeding around the brain that can get worse over time and is life-threatening,” said Dr. Eileen Bulger, chief of trauma at Harborview and lead investigator for the study in Seattle. “This study offers a promising new approach to address such an injury before it has the chance to progress.”
Emergency medical services providers will carry kits that contain either a dose of tranexamic acid or a saline treatment, which they will administer as soon as possible after stabilizing a trauma victim with suspected brain injury. Each of the 1,002 victims treated at one of 10 North America locations will receive either 1 gram of the drug before hospital arrival and 1 after, or 2 grams before arrival and none after. Participants in the control group will be given the standard saline treatment.
The study is unique in that pre-hospital providers may not be able to gain consent from people prior to administration of the drug, as traumatic brain injury often renders people unconscious or disoriented. Patients and their families will be informed about the study as soon as is feasible and will be asked for permission to remain in the study.
The study will be conducted under federal regulations: "Exception from Informed Consent for Studies Conducted in Emergency Settings." The study has been approved by the FDA and reviewed by the University of Washington’s Institutional Review Board.
“Studies conducted under these regulations are crucial to the advancement of emergency research and allow us to develop better practices for treating trauma patients,” Bulger said. “Seattle is at the forefront of emergency medicine: We created Medic One and have one of the top trauma centers in the country. We seek consent whenever possible, but it is almost always unattainable with trauma patients who require immediate treatment.”
The researchers are seeking feedback from the community regarding the conduct of this study. Additionally, individuals can opt out of participating in the study by wearing a bracelet that reads “NO STUDY.” If you are injured, the bracelet dictates that medical care providers exclude you from the research. To opt out, call 206.744.7724 or email email@example.com.
The project is being conducted by the Resuscitation Outcomes Consortium, a clinical research network with centers throughout the United States and Canada. Funding is provided by the National Heart, Lung, and Blood Institute of the National Institutes of Health, the Department of Defense, and other organizations.
Seattle participation begins this fall. The study will conclude after one year.