Pre-hospital Freeze-Dried Plasma for critical bleeding after trauma: A pilot trial

Pre-hospital Freeze-Dried Plasma for critical bleeding after trauma among adult patients receiving blood transfusion: A pilot trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000763741

Enrollment

Registered

2022-05-27

Start date

2022-06-15

Completion date

2022-10-31

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a pilot feasibility trial of freeze-dried plasma vs standard therapy for patients with haemorrhagic shock receiving pre-hospital blood (Population). This will be an open label, randomised controlled trial. The Intervention will be freeze-dried plasma, obtained for the trial from the German Red Cross (LyoPlas N-w). The Comparator will be standard care, which in the Australian context is no plasma or other clotting factor replacement. The primary Outcome will be feasibility of implementation, measured by the proportion of randomised patients who complete the intervention. Secondary outcomes, assessed for possible use as primary outcomes in any subsequent definitive trial, will include mortality at 24 hours and at hospital discharge, coagulation status on arrival to hospital, and total blood product use within 24 hours of hospital arrival.

Interventions

Two units of freeze-dried plasma (total reconstituted volume of 400mL) will be infused intravenously after transfusion of the first unit of red cell concentrate. The infusion will be delivered as fast as possible, 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.

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

Inclusion criteria

1. Adult patients (age greater than or equal to 18 years); 2. Injured through any mechanism; 3. Patients to be transported to a participating trauma centre (The Alfred). 4. Receiving any pre-hospital red cells as per Ambulance Victoria AAV Clinical Practice Guidelines o The transfusion of red cells by HEMS paramedics was implemented in Victoria in April 2011. Primary emergency indication for the administration of red cells is evidence of shock (hypotension and/or tachycardia) following trauma. 5. Able to receive two units of pre-hospital freeze-dried plasma

Exclusion criteria

Extremes of age (>90 years or <18 years) 2. No intravenous access 3. Known pregnancy 4. Palliative care

Outcome results