Synthetic Blood to study blood substitute in brain injury

“Currently ischemic brain damage (brain damage caused by a lack of blood to the brain) is found in 80% of patients who die of severe head injury,” said Dr Ross Bullock, chief of neurotrauma and neurocritical care, at Virginia Commonwealth University and the study’s principle investigator.

“Approximately one third of severe head injury patients show reduced oxygen tension during the first six to 12 hours following injury, which can lead to post-traumatic brain damage. Oxycyte presents a particularly attractive candidate for increasing cerebral oxygen delivery as earlier studies have demonstrated its potential to perfuse and oxygenate tissues in brain contusions, where capillaries are so narrow that red blood cell transport is impeded,” added Dr Bulloch.

In this eight-patient study, Oxycyte will be administered to patients with severe traumatic brain injury and a Glasgow Coma Scale score of 3-9 within 24 hours of the injury’s occurrence. The primary purpose of this study will be to demonstrate Oxycyte’s ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in patients suffering severe head injury.

Additionally, the study will further assess the safety of Oxycyte when given by intravenous infusion. The company expects to report results from this study before the end of 2005.

The company is also currently conducting a phase II study to determine the safety and efficacy of Oxycyte in preventing tissue hypoxia in orthopedic surgical patients (hip surgery). While blood transfusions are not typically administered during this procedure, the amount of blood lost may result in postoperative complications caused by tissue hypoxia. The company expects to complete this trial and report data by the end of 2005.