None listed
Conditions
Brief summary
A prospective, randomised study of seriously injured, shocked adult trauma patients in an urban setting, comparing resuscitation outcomes and serious adverse effects of an intravenous oxygen carrier (HBOC-201) to Normal Saline. In this Victorian study environment it is expected that all patients transported by road to a Major Trauma Centre will have prehospital times of >=20 minutes from the time of first ambulance arrival.
Interventions
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 in
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.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
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
Outcome results
None listed