Accession Number:

ADA591154

Title:

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

Descriptive Note:

Annual rept. 2 Sep 2012-1 Sep 2013

Corporate Author:

MIAMI UNIV FL

Personal Author(s):

Report Date:

2013-10-01

Pagination or Media Count:

29.0

Abstract:

Neurological injury brain and cord is always accompanied by tissue deprivation of glucose and oxygen ischemiahypoxia. Most of the damage seems to be mediated by mechanisms that follow the initial injury secondary mechanisms. Perfluorocarbons PFCs are one of the methods by which oxygen delivery to tissue can be achieved after injury. The rationale for PFCs in traumatic brain injury has been well established in animal studies and early phase 2 clinical trials. Currently three perfluorocarbons are available in the United States for testing, but none of these have been FDA approved and only for one of them Oxycyte has the process of application for FDA approval even been commenced. For the third generation perfluorocarbon Oxycyte a possible side effect that has emerged in humans is transient mild thrombocytopenia. It is uncertain at this time whether this side effect will prove to be a limiting factor which may jeopardize the use of these compounds as a class, or just affect Oxycyte in particular following traumatic brain and spinal cord injury. Any agent which might exacerbate thrombocytopenia in intracranial hemorrhage into traumatic contusions is dangerous for obvious reasons. The purpose of this grant therefore is to cross compare the safety and efficacy of three perfluorocarbons namely Oxycyte, Perftec and Oxygent. We assessed these 3 PFC agents in two head injury models 1 new PENETRATING brain injury animal model human gun-shot wound to head and 2 closed severe rat TBI Fluid Percussion Injury human car crash with a secondary Hypoxic insult. We measured how the PFCs alter the ability of the injured brain 1 to use glucose, oxygen and 2 lower cell death caused by injury, 3 effect on blood clotting.

Subject Categories:

  • Anatomy and Physiology
  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE