Hypothermia for Patients Requiring Evacuation of Subdural Hematoma: Effect on Spreading Depolarizations

Abstract

This report describes Year 2 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, no progress was made as the study remained under ethical review by the Secretary of the Army, as a requirement for a study conducted under Exception from Informed Consent (EFIC). Alternatives to use of EFIC were explored. At the end of this period, the HOPES Data and Safety Monitoring Board conducted a scheduled interim review and recommended to stop the trial due to futility, which precludes any possibility to conduct the study as presently described in the HOPES protocol. The investigators are formulating a proposed revision of the Statement of Work with alternate plans to achieve the objectives of the study.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2018
Accession Number
AD1063798

Entities

People

  • Jed A Hartings

Organizations

  • University of Cincinnati

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Biomedical Research
  • Brain
  • Brain Injuries
  • Craniocerebral Trauma
  • Department Of Defense
  • Depolarization
  • Electronic Mail
  • Evacuation
  • Health Services
  • Hypothermia
  • Medical Personnel
  • Monitoring
  • Professional Development
  • Standards
  • Surgery
  • Technology Transfer
  • Temperature Control

Readers

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  • Exercise and Sports Science.
  • Neurotrauma and Rehabilitation Medicine.