A study comparing resuscitation outcomes following administration of an intravenous oxygen carrier (HBOC-201) to Normal Saline in urban adult trauma patients.

INTERVENTION: Initial intervention criteria: A Shock Index (i.e. Heart Rate / Systolic Blood Pressure) >= 1.0 and other eligibility criteria met Intervention: Initial intravenous infusion (usually over 20 minutes) of HBOC‐201 (250 ml) or NS ( in 250 ml increments up to 1,000ml ml) HBOC‐201 is an experimental intravenous fluid with oxygen carrying capacity derived from bovine red blood cell hemoglobin. The HBOC‐201 is a deep red coloured fluid. Maximum total dose: Doses of IV fluid following initial infusion will be HBOC‐201 (250 ml) or NS solution to maintain BP > 70 mmHg depending on randomisation arm. If further IV fluid is indicated in the HBOC‐201 arm after a maximum limit of 2 units of HBOC‐201 [2 doses of 250 ml] has been infused standard care (NS) will be administered. If the Systolic BP is < 70mmHg whilst the HBOC‐201 is being infused either as the initial or the second dose of 250 ml, NS will also be administered via a second IV line until the BP is > 70mmHg. IV infusion stopping criterion: A Systolic Blood Pressure > 120 mmHg and Pulse Rate < 120 beats/minute. CONDITION: Haemorrhagic shock Major Trauma PRIMARY OUTCOME: Mortality as assessed by hospital records SECONDARY OUTCOME: Serious adverse events, defined as abnormalities in ; 1. Haemoglobin levels on days 1‐4, 7, 14 and 28 ; 2. Acute renal injury as defined by the RIFLE criteria through urine output and creatinine ; 3. Acute myocardial infarction (defined as normal Troponin I on admission with subsequent Troponin I rise and diagnostic ECG changes) ; 4. Ischaemic stroke ; 5. Anaphylaxis ; 6. Blood and blood product administration ; 7. Cardiac arrest ; 8. Length of Stay in ICU and hospital ward. ; ; Assessed and notified by researchers involved in the care of the patient, research personnel involved with completion of case reports through contact at the decided intervals, and retrospectively through hospital records in cases of missing data. INCLUSION CRITERIA: 1) Age 18 to less than 55 years 2) Injury with obvious/suspected haemorrhagic shock 3) Pre‐hospital Shock Index >=1.0 4) Road transport by MICA paramedic to either The Alfred or the Royal Melbourne Hospitals 5) External haemorrhage control attempted in patients with external bleeding 6) IV access secured