New trial will test whether a medication can improve recovery after life-threatening traumatic brain injury
Toronto, August 7, 2015
A multi-site brain injury research trial launched in Toronto on Aug. 5. The study will test whether people who have life-threatening or life-altering traumatic brain injuries do better when they receive a medication used to stabilize bleeding.
The medication, called tranexamic acid, is better known as TXA and is used to stabilize bleeding in any part of the body after trauma. For this study, researchers will compare outcomes when paramedics and Level 1 trauma centres give patients with severe head trauma either TXA or placebo.
The year-long study will enroll 963 patients across 13 North American cities and monitor their recoveries. Results will determine whether TXA improves recovery and quality of life for traumatic brain injury victims, when given as soon as possible after injury.
As of Aug. 5, when responders from Toronto Paramedic Services suspect that an accident victim has a traumatic brain injury, they’ll use information such as blood pressure, pulse and level of awareness to determine whether a patient is eligible to take part in the study. Paramedics from Ornge air ambulance will begin enrolling study patients in the coming weeks.
Eligible patients enrolled in this study will be randomly assigned to one of three groups:
- Group 1 will receive a one-gram dose of TXA from the medics and a one-gram dose of TXA in the hospital
- Group 2 will receive a two-gram dose of TXA from the medics and a salt-water solution in the hospital
- Group 3 will receive salt-water solutions from both the paramedic and the hospital teams
Aside from the delivery of TXA or placebo, all patients will receive standard care for trauma.
Dr. Laurie Morrison is the Toronto lead for the international study. Dr. Morrison is the director of Rescu –a group that studies out-of-hospital emergency health care– and a scientist with the Li Ka Shing Knowledge Institute of St. Michael's. Dr. Sandro Rizoli is the study’s site lead at St. Michael’s, where he is also director of Trauma and a scientist with the hospital’s Keenan Research Centre for Biomedical Science. Sunnybrook Health Sciences Centre, where Toronto’s other Level 1 trauma centre is located, is also participating in the study.
Consent is required from participants before a product is delivered in most clinical trials. However, because this study will be conducted on people who have suffered trauma and are unlikely to be conscious, the consent process has been waived by Health Canada and the Research Ethics Boards of St. Michael’s and Sunnybrook.
Participants and families will be informed and asked for consent to continue in the study once the medical emergency has stabilized. Patients who chose not to participate in this study will receive all of the standard care determined by their physicians.
About St. Michael's Hospital
St. Michael’s Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future health care professionals in 27 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, care of the homeless and global health are among the hospital’s recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Centre, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael's Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto.