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

• Conditions: Bleeding; Traumatic haemorrhage; Blood - Clotting disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12615001293550
• Lead Sponsor: Investigator Initiated- Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified