Hypothermia for Patients Requiring Evacuation of Subdural Hematoma: Effect on Spreading Depolarizations
Technical Report,30 Sep 2016,29 Sep 2017
University of Cincinnati Cincinnati United States
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This report describes Year 1 progress in a sub-study of the HOPES trial to assess the effects of hypothermia on the pathologic mechanism of spreading depolarizations SD. HOPES is a randomized multi-center clinical study of very early hypothermia in patients with traumatic brain injury who require emergent surgical evacuation of a subdural hematoma. In this period, we developed methods and manuals for the use of electrocorticography to monitor SD, and incorporated procedures into HOPES protocols and databases. Subaward contracts were established and local ethical study approvals were obtained at three of four proposed study sites a fourth site has withdrawn from the study and a replacement has been identified. The protocol, utilizing exception from informed consent EFIC, was submitted to the Office of the Secretary of the Army for approval and remains under review. If approval is received, site initiation visits will be completed and sites will be opened for enrollment.
- Stress Physiology