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

Phase 2

• Conditions: Haemorrhagic shock; Major Trauma; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12615000522516
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

1) Penetrating Traumatic Brain Injury
2) Paralysis (not as a result of paralysing agent administration).
3) Pregnancy—known or suspected by next of kin if at scene
4) Cardiac arrest (an absence of spontaneous circulation)
5) Known allergy to HBOC-201
6) Known opposition to HBOC-201 administration
7) Burn > 20% body surface area (BSA) (partial or full thickness)
8) Blood for transfusion available at scene

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality as assessed by hospital records[Upto 28days after date of injury or at discharge]

Secondary Outcome Measures

Name	Time	Method
Serious adverse events, defined as abnormalities in <br>1. Haemoglobin levels on days 1-4, 7, 14 and 28<br>2. Acute renal injury as defined by the RIFLE criteria through urine output and creatinine <br>3. Acute myocardial infarction (defined as normal Troponin I on admission with subsequent Troponin I rise and diagnostic ECG changes)<br>4. Ischaemic stroke<br>5. Anaphylaxis <br>6. Blood and blood product administration<br>7. Cardiac arrest <br>8. Length of Stay in ICU and hospital ward. <br><br>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.[Upto 28days after date of injury or at discharge]