The study is being conducted under an investigational device exemption by Guy Clifton and other researchers at the University of Texas Health Science Center in Houston, whose institutional review board has also approved the study.
The study will explore whether the induction of hypothermia to 35 degrees Celsius in two-and-a-half hours after severe traumatic brain injury and reaching 33 degrees Celsius by four hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months and 12 months after injury compared to patients randomized to normothermia.
The 240-patient study is being sponsored by the National Institute of Neurological Disorders and Stroke. The study currently includes five participating hospitals in addition to the University of Texas.
Milton Frank, COO of Life Recovery Systems (LRS), said: “If the study proves to be successful, the ThermoSuit system could potentially benefit thousands of patients with traumatic brain injury. Traumatic brain injury is the ‘signature wound’ of the Iraq war, and the company is hopeful that early cooling will be beneficial to a number of military casualties.”