None listed
Conditions
Brief summary
Traumatic brain injury (TBI) remains the leading cause of death after injury. In animal models, early treatment with plasma significantly attenuated neurological impairment after TBI. Early treatment with plasma is therefore a potential therapy for moderate to severe TBI that requires assessment in randomised trials. The aim of this study is to undertake a pilot RCT of early plasma versus standard care among patients with moderate to severe TBI.
Interventions
Two units of freeze-dried plasma (total reconstituted volume of 400mL) will be infused intravenously by pre-hospital clinicians (paramedics or doctors). The infusion will be delivered as fast as possible (usually over 10 minutes), as tolerated by the intravenous access. The infusion of freeze-dried plasma, once commenced, will be continued in hospital until completion of the entire intervention dose.
All other standard care for patients with traumatic brain injury will be provided as dictated by
Two units of freeze-dried plasma (total reconstituted volume of 400mL) will be infused intravenously by pre-hospital clinicians (paramedics or doctors). The infusion will be delivered as fast as possible (usually over 10 minutes), as tolerated by the intravenous access. The infusion of freeze-dried plasma, once commenced, will be continued in hospital until completion of the entire intervention dose. All other standard care for patients with traumatic brain injury will be provided as dictated by prehospital clinical practice guidelines. This may include intubation, moderate hyperventilation and hyperosmolar therapy.
Sponsors
Bayside 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 90 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients (age >or=18 years); 2. Injured through blunt mechanisms; 3. Patients to be transported to a participating trauma centre (The Alfred, Royal Melbourne Hospital, Princess Alexandra Hospital or Royal Brisbane and Women’s Hospital). 4. Initial Glasgow Coma Scale score <14. 5. Judged by the prehospital clinician to have moderate to severe isolated TBI
Exclusion criteria
1. Extremes of age (>90 years or <18 years) 2. No intravenous access 3. Known pregnancy 4. Palliative care
Outcome results
None listed