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Fibrinogen Early In Severe Trauma studY Junior (FEISTY Jnr)

Primary Purpose

Trauma, Hemorrhage, Coagulopathy

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Fibrinogen Concentrate
Cryoprecipitate
Sponsored by
Gold Coast Hospital and Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring Fibrinogen Concentrate, Cryoprecipitate

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Childrens HospitalRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Lady Cilento Children's HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Cairns HospitalRecruiting
  • Gold Coast University HospitalRecruiting
  • Mackay Base HospitalRecruiting
  • Rockhampton HospitalRecruiting
  • Townsville HospitalRecruiting
  • Royal Adelaide HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fibrinogen Concentrate

Cryoprecipitate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
Time to fibrinogen replacement

Secondary Outcome Measures

Transfusion Requirements
In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs
Duration of bleeding episode or time until surgical control
Duration bleeding episode
Intensive Care Unit LOS
ICU LOS
Hospital LOS
Hospital LOS
Adverse Events
Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications
All Cause Mortality
Mortality at 4, 6, 24 hours and up to 90 days
Functional Outcomes GOS-E Paediatrics
Functional Outcome Measures at 60 and 90 Days

Full Information

First Posted
March 23, 2018
Last Updated
June 25, 2020
Sponsor
Gold Coast Hospital and Health Service
Collaborators
Emergency Medicine Foundation, National Blood Authority, Australian Red Cross
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1. Study Identification

Unique Protocol Identification Number
NCT03508141
Brief Title
Fibrinogen Early In Severe Trauma studY Junior
Acronym
FEISTY Jnr
Official Title
Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gold Coast Hospital and Health Service
Collaborators
Emergency Medicine Foundation, National Blood Authority, Australian Red Cross

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in paediatric trauma patients Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma Hypo/dysfibrinogenaemia plays an important role in TIC Early replacement of fibrinogen may improve outcomes Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Hemorrhage, Coagulopathy, Pediatrics
Keywords
Fibrinogen Concentrate, Cryoprecipitate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibrinogen Concentrate
Arm Type
Experimental
Arm Description
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
Arm Title
Cryoprecipitate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fibrinogen Concentrate
Other Intervention Name(s)
Riastap
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Cryoprecipitate
Intervention Description
Comparator
Primary Outcome Measure Information:
Title
Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
Description
Time to fibrinogen replacement
Time Frame
3 Hours
Secondary Outcome Measure Information:
Title
Transfusion Requirements
Description
In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs
Time Frame
Up to 48 hours after Trauma Unit presentation
Title
Duration of bleeding episode or time until surgical control
Description
Duration bleeding episode
Time Frame
It is anticipated that haemorrhage control will be achieved within 12 hours
Title
Intensive Care Unit LOS
Description
ICU LOS
Time Frame
1 Year
Title
Hospital LOS
Description
Hospital LOS
Time Frame
1 Year
Title
Adverse Events
Description
Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications
Time Frame
1 Year
Title
All Cause Mortality
Description
Mortality at 4, 6, 24 hours and up to 90 days
Time Frame
Up to 90 Days
Title
Functional Outcomes GOS-E Paediatrics
Description
Functional Outcome Measures at 60 and 90 Days
Time Frame
Up to 90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child affected by trauma (3 months to 18 years) Judged to have significant haemorrhage OR predicted to require significant transfusion by the treating clinician Activation of Local MHP or transfusion of emergency red blood cells (Pre-hospital or at Trauma Centre) Exclusion Criteria: Injury judged incompatible with survival Randomisation unable to occur within 6 hours of hospital admission Pregnancy Known personal or parental objection to blood products Known coagulation disorder (i.e. haemophilia, von Willebrand disease) Previous dedicated fibrinogen replacement this admission Pre-Trauma Centre dedicated fibrinogen replacement Participation in competing study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Winearls, MBBS
Phone
+61756875684
Email
james.winearls@health.qld.gov.au
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Wake, BN
Phone
+61756874149
Email
elizabeth.wake@health.qld.gov.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shane George, MBBS
Organizational Affiliation
Lady Cilento Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Childrens Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Jansen
Email
melanie.jansen@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Melanie Jansen
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cath Hurn, MBBS
Facility Name
Lady Cilento Children's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr George, MBBS
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glenn Ryan, MBBS
Facility Name
Cairns Hospital
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4211
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cath Tacon, FCICM
Email
cath.tacon@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Cath Tacon, FCICM
Facility Name
Gold Coast University Hospital
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Winearls, MBBS
Email
james.winearls@health.qld.gov.au
Facility Name
Mackay Base Hospital
City
Mackay
State/Province
Queensland
ZIP/Postal Code
4211
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anni Paasilahti, FCICM
Email
anni.paasilahti@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Anni Paasilahti, FCICM
Facility Name
Rockhampton Hospital
City
Rockhampton
State/Province
Queensland
ZIP/Postal Code
4211
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Miles, MBBS
Email
helen.miles@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Helen Miles, MBBS
Facility Name
Townsville Hospital
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melita Trout, MBBS
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Ellis, MBBS, FACEM, FCICM, FIMC
Email
dan.ellis@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Dan Ellis, MBBS, FACEM, FCICM, FIMC

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35508351
Citation
George S, Wake E, Jansen M, Roy J, Maconachie S, Paasilahti A, Wiseman G, Gibbons K, Winearls J; FEISTY Investigators. Fibrinogen Early In Severe paediatric Trauma studY (FEISTY junior): protocol for a randomised controlled trial. BMJ Open. 2022 May 4;12(5):e057780. doi: 10.1136/bmjopen-2021-057780.
Results Reference
derived

Learn more about this trial

Fibrinogen Early In Severe Trauma studY Junior

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