Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI) (STOP-TBI)

Inclusion Criteria:

• Male or female 18 - 70 years of age, inclusive, at the time of study entry
• Non-penetrating traumatic brain injury
• Evidence of severe TBI by clinical evaluation, clinical indication for ICP monitoring, GCS assessment (3-9, obtained any time prior to dosing and including patients who deteriorate to severe TBI after arrival in the hospital) and abnormalities on head CT scan (e.g., Marshall Grade II-V or equivalent)
• At least one reactive pupil at screening, confirmed again just prior to the administration of study drug
• Able to begin the infusion of study drug within 12 hours of injury
• Weight ≥45 kg
• If a patient, due to his or her injuries is unable to provide written informed consent, then written informed consent may be obtained: A) From the patient's family or legally authorized representative through the conveyance of Presumable Will or B) Through discussions with the Principal Investigator an independent physician may approve a patient's participation in the study. In this process, conveyance of Presumable Will is provided by the patient's family or legally authorized representative, if available, at a later date.

Exclusion Criteria:

• Penetrating traumatic brain injury
• Absence of a motor response
• Bilaterally fixed and dilated pupils
• Known allergy to any component of Oxycyte or known severe allergy to eggs
• History of severe TBI (previous to the current TBI) or any prior cerebral injury that required hospitalization and that may, in the Investigator's opinion, interfere with the results of this study
• Known history of HIV
• Known history of major liver disease (e.g., liver failure, necrosis or cirrhosis) or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Immersion injury
• Known or suspected brain tumor
• Known history of any of the following neurodegenerative diseases: Parkinson's Disease, Huntington's Disease, major stroke, seizure disorder, Multiple Sclerosis or cerebral aneurysm (unless clipped and stable, in which case patient may be included)
• Platelet count <100,000/mm3 at screening, prior to transfusion of any platelets
• In the judgment of the Investigator, any clinically significant prolonged clotting time on International Normalized ratio (INR), prothrombin time (PT) or activated partial thromboplastin time (aPTT), or any other coagulation test performed
• Major liver, kidney, or cardiac injury requiring operative intervention
• Not expected to survive the next 24 hours
• Morbidly obese (BMI >40)
• Concurrent use of Plavix® (clopidogrel bisulfate), Pradaxa® (dabigatran elexilate) or an anti- coagulant other than ≤100 mg/day aspirin for any condition
• One or more of the following liver function test results: Total Bilirubin >2 x ULN, ALT >2.5 x ULN, or AST 2.5 > x ULN
• Major pulmonary injury, including lung contusion, severe atelectasis, acute respiratory distress syndrome, or acute aspiration pneumonitis
• Severe COPD, pulmonary edema, or congestive heart failure in the judgment of the Investigator
• Any life threatening condition prior to the current injury or other diseases or disorders that, in the Investigator's opinion, may put the patient at undue risk or confound the results of the study
• Any known hematological or coagulopathic disorder that, in the Investigator's opinion, is likely to significantly impair platelet function or coagulation (e.g., hemophilia, von Willebrand's disease, myelodysplastic syndrome)
• Hemodynamically unstable ((defined as a mean arterial pressure (MAP) <70mmHg, or requiring >6L colloid or crystalloid fluid resuscitation))
• Cardiopulmonary resuscitation required following the current injury
• Women with a positive urine pregnancy test at screening
• Current participation in another clinical trial with an investigational product, or participation in such a clinical trial within 30 days prior to screening
• Patients serving in the military forces at the time of screening who (if required) do not have the necessary approval from the appropriate authorities
• Inability to obtain Informed Consent