Fibrinogen Early In Severe Trauma studY Junior (FEISTY Jnr)

June 25, 2020 updated by: Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Gold Coast Hospital and Health Service

Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial

  1. Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in paediatric trauma patients
  2. Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
  3. Hypo/dysfibrinogenaemia plays an important role in TIC
  4. Early replacement of fibrinogen may improve outcomes
  5. Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
  6. The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
  7. Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
  8. It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
  9. Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
  10. Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay

12. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in paediatric trauma patients before widespread adoption makes performing such studies unfeasible

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Glenn Ryan, MBBS
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital
        • Contact:
          • Cath Hurn, MBBS
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Lady Cilento Children's Hospital
        • Contact:
          • Dr George, MBBS
      • Cairns, Queensland, Australia, 4211
      • Gold Coast, Queensland, Australia, 4215
      • Mackay, Queensland, Australia, 4211
      • Rockhampton, Queensland, Australia, 4211
      • Townsville, Queensland, Australia, 4814
        • Recruiting
        • Townsville Hospital
        • Contact:
          • Melita Trout, MBBS
    • South Australia
      • Adelaide, South Australia, Australia
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Dan Ellis, MBBS, FACEM, FCICM, FIMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Child affected by trauma (3 months to 18 years)
  2. Judged to have significant haemorrhage OR predicted to require significant transfusion by the treating clinician
  3. Activation of Local MHP or transfusion of emergency red blood cells (Pre-hospital or at Trauma Centre)

Exclusion Criteria:

  1. Injury judged incompatible with survival
  2. Randomisation unable to occur within 6 hours of hospital admission
  3. Pregnancy
  4. Known personal or parental objection to blood products
  5. Known coagulation disorder (i.e. haemophilia, von Willebrand disease)
  6. Previous dedicated fibrinogen replacement this admission
  7. Pre-Trauma Centre dedicated fibrinogen replacement
  8. Participation in competing study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fibrinogen Concentrate
Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 60mg/kg FC FIBTEM A5 1-4mm = 50mg/kg FC FIBTEM A5 5-6mm = 40mg/kg FC FIBTEM A5 7-8mm = 30mg/kg FC FIBTEM A5 9-10mm = 20mg/kg FC
Drug: Fibrinogen Concentrate
Experimental
Other Names:
  • Riastap
Active Comparator: Cryoprecipitate
Fibrinogen Replacement using Cryoprecipitate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 6ml/kg Cryoprecipitate FIBTEM A5 1-4mm = 5ml/kg Cryoprecipitate FIBTEM A5 5-6mm = 4ml/kg Cryoprecipitate FIBTEM A5 7-8mm = 3ml/kg Cryoprecipitate FIBTEM A5 9-10mm = 2ml/kg Cryoprecipitate
Drug: Cryoprecipitate
Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
Time Frame: 3 Hours
Time to fibrinogen replacement
3 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion Requirements
Time Frame: Up to 48 hours after Trauma Unit presentation
In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs
Up to 48 hours after Trauma Unit presentation
Duration of bleeding episode or time until surgical control
Time Frame: It is anticipated that haemorrhage control will be achieved within 12 hours
Duration bleeding episode
It is anticipated that haemorrhage control will be achieved within 12 hours
Intensive Care Unit LOS
Time Frame: 1 Year
ICU LOS
1 Year
Hospital LOS
Time Frame: 1 Year
Hospital LOS
1 Year
Adverse Events
Time Frame: 1 Year
Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications
1 Year
All Cause Mortality
Time Frame: Up to 90 Days
Mortality at 4, 6, 24 hours and up to 90 days
Up to 90 Days
Functional Outcomes GOS-E Paediatrics
Time Frame: Up to 90 Days
Functional Outcome Measures at 60 and 90 Days
Up to 90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gold Coast Hospital and Health Service

Collaborators

Emergency Medicine Foundation
National Blood Authority
Australian Red Cross

Investigators

  • Principal Investigator: Shane George, MBBS, Lady Cilento Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 16, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 25, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEISTY Jnr 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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