RecruitingPhase 2ACTRN12623000812695

Efficacy and safety of prehospital fibrinogen early in severe trauma study: A feasibility phase II study (PRE-FEISTY II) (Stage 1).

Efficacy and safety of prehospital fibrinogen early in severe trauma study: A fphase II study (PRE-FEISTY II)(Stage 1)


Sponsor

New South Wales Ambulance

Enrollment

23 participants

Start Date

Dec 10, 2023

Study Type

Interventional

Conditions

Summary

This study aims to investigate the feasibility and effect of administering fibrinogen concentrate in the setting of severe traumatic bleeding in the prehospital setting, This is being done to evaluate the possibility of conducting a prehospital arm of the forthcoming FEISTY II study.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When someone suffers a serious injury and is losing a lot of blood, their body's ability to clot that blood can become severely impaired — making the bleeding much harder to stop. Fibrinogen is a protein that plays a key role in blood clotting, and giving extra fibrinogen early may help control bleeding before the patient even reaches the hospital. This study is testing whether it is practical and safe to give fibrinogen concentrate to seriously injured patients in the ambulance, before they arrive at hospital. The study is a feasibility trial, meaning it is designed to find out whether running a larger definitive trial in the prehospital setting is practical and to gather early safety data. Participants will be seriously injured adults who are already receiving blood transfusions in the ambulance. You may be eligible if you are an adult (18 or older) who has sustained a serious injury with ongoing bleeding and is already receiving blood products before reaching hospital. Patients whose injuries are incompatible with survival, who are known to be pregnant, who have blood clotting disorders, or who object to blood products are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Intravenous or intraosseous administration of three vials (approximately 3g) of fibrinogen concentrate (RiaStap®) following the conclusion of initial resuscitation and stabilisation, anticipated to be

Intravenous or intraosseous administration of three vials (approximately 3g) of fibrinogen concentrate (RiaStap®) following the conclusion of initial resuscitation and stabilisation, anticipated to be in the timeframe of approximately 15 to 60 minutes following arrival of a prehospital medical team. The intervention will be delivered once. Adherence to the intervention will be monitored by regular ongoing audit of all patients treated by our service who receive prehospital blood transfusion. This audit is already embedded in our routine clinical governance procedures.


Locations(4)

NSW Ambulance Aeromedical Operations- Bankstown Base - Condell Park

NSW,QLD, Australia

NSW Ambulance Aeromedical Operations- Wollongong Base - Albion Park Rail

NSW,QLD, Australia

NSW Ambulance Aeromedical Operations- Orange Base - Huntley

NSW,QLD, Australia

Lismore Retrieval Service Helicopter Base - Loftville

NSW,QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12623000812695