FIT A pilot study evaluating the feasibility and effects of early administration of Fibrinogen concentrate In adults with Traumatic haemorrhage

To determine the feasibility of early administration of Fibrinogen concentrate in trauma patients with ongoing haemorrhagic shock requiring activation of the massive transfusion protocol

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001293550

Acronym

FIT

Enrollment

Registered

2015-11-27

Start date

2016-01-20

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

None listed

Brief summary

One third of patients affected by severe trauma die from uncontrolled bleeding. Many of these patients are found to have abnormalities of the clotting system collectively known as ‘acute traumatic coagulopathy’ (ATC). The two most important abnormalities in ATC are a low fibrinogen and increased clot breakdown. It has been hypothesised, and there are some non-randomised studies that show that treatment with fibrinogen therapy in trauma patients who are bleeding can stop bleeding more effectively than standard care, reduce transfusion needs and may reduce death rates. This study will look at the effects of infusing fibrinogen concentrate (FgC, a concentrated source of fibrinogen) to adult trauma patients as early as possible (within 45 minutes of admission to hospital). It has been shown in a large trauma randomised controlled trial that treatment for bleeding has better outcomes if delivered to patients quickly. This study will evaluate whether it is possible to enrol patients, deliver and infuse drug within 45 minutes and will also look at laboratory and clinical outcome measures.

Interventions

Fibrinogen concentrate will be given via an infusion at the beggining of the massive transfusion protocol activation. Dosage is a single 6g dose of FgC, 6x1gm vial reconstituted with 50ml saline per vial (RiaSTAP Registered Trademark, CSL Behring, Australia) IV given as a slow push injection over 5 minutes.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. The participant is judged to be an adult (aged 18 years or over) and is affected by traumatic injury 2. The participant is deemed by the attending clinician to have on-going active haemorrhage with shock AND REQUIRES: 3. activation of the local massive transfusion protocol (MTP) for management of severe blood loss and/or transfusion of emergency (Group O) red cells

Exclusion criteria

1. The participant has been transferred from another hospital 2. The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life 3. More than 3 hours have elapsed from the time of injury 4. The participant is pregnant 5. Severe isolated traumatic brain injury (TBI) or unsalvageable head injury 6. Known objection to the administration of human blood products 7. Participation in a competing study

Outcome results