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

Phase 2

Recruiting

• Conditions: Acute traumatic haemorrhage; Blood - Clotting disorders; Emergency medicine - Other emergency care; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12623000812695
• Lead Sponsor: ew South Wales Ambulance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Adult patient (aged greater than or equal to 18 years).
Judged to have ongoing haemorrhage by the treating clinician.
Receiving pre-hospital blood transfusion

Exclusion Criteria

1.Injury judged incompatible with survival
2.Enrolment unable to occur within 6 hours of injury
3.Known pregnancy
4.Known genetic or drug induced coagulation disorder
5.Known objection to blood products
6.Dedicated prior fibrinogen replacement
7.Participation in a competing study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a fibrinogen level > 2.0 g/L assessed by laboratory testing following hospital arrival.[ On first testing following arrival in hospital (anticipated within 30 minutes of hospital arrival).]