NCT03508141

Brief Summary

  1. 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. 2.Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
  3. 3.Hypo/dysfibrinogenaemia plays an important role in TIC
  4. 4.Early replacement of fibrinogen may improve outcomes
  5. 5.Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
  6. 6.The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
  7. 7.Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
  8. 8.It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
  9. 9.Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
  10. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2018

Typical duration for phase_2

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

3 years

First QC Date

March 23, 2018

Last Update Submit

June 25, 2020

Conditions

TraumaHemorrhageCoagulopathyPediatrics

Keywords

Fibrinogen ConcentrateCryoprecipitate

Outcome Measures

Primary Outcomes (1)

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

    Time to fibrinogen replacement

    3 Hours

Secondary Outcomes (7)

  • Transfusion Requirements

    Up to 48 hours after Trauma Unit presentation

  • Duration of bleeding episode or time until surgical control

    It is anticipated that haemorrhage control will be achieved within 12 hours

  • Intensive Care Unit LOS

    1 Year

  • Hospital LOS

    1 Year

  • Adverse Events

    1 Year

  • +2 more secondary outcomes

Study Arms (2)

Fibrinogen Concentrate

EXPERIMENTAL

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

Cryoprecipitate

ACTIVE COMPARATOR

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

Interventions

Fibrinogen ConcentrateDRUG

Experimental

Also known as: Riastap
Fibrinogen Concentrate
CryoprecipitateDRUG

Comparator

Cryoprecipitate

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Westmead Childrens Hospital

Sydney, New South Wales, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

Lady Cilento Children's Hospital

Brisbane, Queensland, 4101, Australia

RECRUITING

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

RECRUITING

Cairns Hospital

Cairns, Queensland, 4211, Australia

RECRUITING

Gold Coast University Hospital

Gold Coast, Queensland, 4215, Australia

RECRUITING

Mackay Base Hospital

Mackay, Queensland, 4211, Australia

RECRUITING

Rockhampton Hospital

Rockhampton, Queensland, 4211, Australia

RECRUITING

Townsville Hospital

Townsville, Queensland, 4814, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35508351DERIVED

MeSH Terms

Conditions

Wounds and InjuriesHemorrhageHemostatic Disorders

Interventions

Fibrinogencryoprecipitate coagulum

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological Factors

Study Officials

  • Shane George, MBBS

    Lady Cilento Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Winearls, MBBS

CONTACT

+61756875684james.winearls@health.qld.gov.au

Elizabeth Wake, BN

CONTACT

+61756874149elizabeth.wake@health.qld.gov.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr James Winearls, Consultant Intensivist GCUH

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 25, 2018

Study Start

July 1, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(10)