Clinical Phase IIB Trial of Oxycyte Perflurocarbon in Severe Human Traumatic Brain Injury

Abstract

Cerebral ischemia is a common secondary consequence of traumatic brain injury (TBI), including penetrating TBI. Experimental models of closed brain injury (fluid percussion, subdural hematoma, etc.) have demonstrated a neuroprotective effect after perfluorocarbon (PFC) administration, however, there is no data relating to a pharmacological effect of PFC in penetrating ballistic-like brain injury (PBBI;Tortella model) that is characterized by acute, sustained significant hypoxia. In this report we present data on the severity of hypoxia, glucose utilization, histopathology and oxygen metabolism( Vo2) following PBBI, and changes in these parameters following PFC administration in the PBBI model, as well as studies on effect of PFC on blood clotting of normal human blood. The data shows little effect of any of the 3 PFC s on the hypoxia observed in this type of brain injury. In the same PBBI injury model for the first time we observed no effect of PFC s upon VO2 (oxygen consumption) but the studies are incomplete. Surprisingly, the 2 PFc s so far tested significantly improved Glucose utilization (anaerobic glycolysis) but the studies are incomplete. The. We are currently further investigating the effects of PFC administration on this PBBI induced global glucose utilization. The Cell counting study aimed at uncovering any neuroprotective effects of PFC administration on PBBI induced neurodegeneration did not reveal significant global improvement, but the counts are incomplete. Interestingly the three PFCs tested had very different effects on the thromboelastography profile of normal human blood. Only Perftec demonstrated an apparent anticoagulant effect, using Thromboelastography. This data will be used to assess the safety/efficacy profile of each PFC, in the PTBI and closed TBI models. About 60% of experiments are complete, and data analysis is ongoing.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2012
Accession Number
ADA570404

Entities

People

  • M. R. Bullock

Organizations

  • University of Miami

Tags

DTIC Thesaurus Topics

  • Anticoagulants
  • Blood
  • Blood Coagulation
  • Brain Injuries
  • Cell Physiological Processes
  • Cells
  • Cerebrovascular Disorders
  • Craniocerebral Trauma
  • Data Analysis
  • Glucose
  • Histological Techniques
  • Histology
  • Medical Personnel
  • Neurodegeneration
  • Students
  • Tissues
  • Wounds And Injuries

Readers

  • Allergy and Immunology.
  • Cardiovascular Physiology
  • Neurotrauma and Rehabilitation Medicine.