FDA Approves Testing to Explore Effectiveness of Rapid Patient Cooling in Traumatic Brain Injury Cases
The study is being conducted under an Investigational Device Exemption byDr. Guy Clifton and other researchers at the University of Texas HealthScience Center in Houston, whose Institutional Review Board has also approvedthe study.
The study will explore whether the induction of hypothermia to 35 degreesC in two-and-a-half hours after severe traumatic brain injury and reaching 33degrees C by four hours after injury and maintained for 48 hours in patientsaged 16-45 will result in an increased number of patients with good outcomesat six months and 12 months after injury compared to patients randomized tonormothermia. Previous research conducted by the Houston-based researchersindicated that later cooling was ineffective in reducing brain injury. Theresearchers concluded that more rapid cooling methods are needed to achieve abenefit in these patients.
"If the study proves to be successful, the ThermoSuit System couldpotentially benefit thousands of patients with traumatic brain injury," saidMilton Frank, Life Recovery Systems' COO. "Traumatic brain injury is the'signature wound' of the Iraq war, and LRS is hopeful that early cooling willbe beneficial to a number of military casualties."
The ThermoSuit System, a non-invasive cooling technology was adopted forthe current study because of its rapid cooling capabilities, safety and easeof use in an emergency department. While other non-invasive cooling methodstypically require hours to cool the patient to the target temperatures of thisprotocol, the ThermoSuit System is able to provide the desired amount ofcooling in less than 30 minutes.
The 240-patient study titled, "National Acute Brain Injury Study:Hypothermia IIR" (NABIS:HIIR), is being sponsored by the National Institute ofNeurological Disorders and Stroke (NINDS). The study currently includes fiveparticipating hospitals in addition to the University of Texas.
Life Recovery Systems developed and markets the ThermoSuit(R) System, thefastest noninvasive hypothermia device. The first products were shipped inFebruary 2007. The system continuously pumps a thin film of ice water aroundthe patient's body until the temperature reaches a preset level. This uniquetechnology cools patients at a rate of one degree centigrade for every sevenminutes of treatment. The duration of cooling treatment required to achievethe target temperature is typically 20 to 30 minutes. Numerous publicationssupport the potential benefits of rapid cooling. After cooling, the patient isremoved from the ThermoSuit System and can easily be transported around thehospital for other therapeutic treatments. Patients cooled with theThermoSuit System typically stay cold for hours with little or no furthermaintenance cooling required.
For additional information about the NABIS:HIIR study, please go tohttp://clinicaltrials.gov/ct2/show/NCT00178711?cond=%22Hypothermia%22&rank=22
For additional information about Life Recovery Systems and the ThermoSuitSystem, go to http://www.life-recovery.com .Note to Editors: Photos of the ThermoSuit System are available. Contact: Judd Cohen Cohen Communications 212-682-7838 email@example.com
SOURCE Life Recovery Systems
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