TraumaPhase 2FEISTY JnrNCT03508141
Fibrinogen Early In Severe Trauma studY Junior
A Phase 2 study testing Fibrinogen Concentrate and Cryoprecipitate in people with Trauma and Hemorrhage, run by Gold Coast Hospital and Health Service at 10 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Trauma, Hemorrhage, Coagulopathy
- What is being tested?
- Fibrinogen Concentrate and Cryoprecipitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 10 sitesAustralia
- Study dates
- 1 Jul 2018to 30 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites, 10 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia
Daniel Ellis, MBBS, FACEM, FCICM, FIMC, dan.ellis@sa.gov.au
Dan Ellis, MBBS, FACEM, FCICM, FIMC
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Cath Hurn, MBBS
- Recruiting
Lady Cilento Children's Hospital
Brisbane, Queensland, 4101
Dr George, MBBS
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Glenn Ryan, MBBS
- Recruiting
Cairns Hospital
Cairns, Queensland, 4211
Cath Tacon, FCICM, cath.tacon@health.qld.gov.au
Cath Tacon, FCICM
- Recruiting
Gold Coast University Hospital
Gold Coast, Queensland, 4215
James Winearls, MBBS, james.winearls@health.qld.gov.au
- Recruiting
Mackay Base Hospital
Mackay, Queensland, 4211
Anni Paasilahti, FCICM, anni.paasilahti@health.qld.gov.au
Anni Paasilahti, FCICM
- Recruiting
Rockhampton Hospital
Rockhampton, Queensland, 4211
Helen Miles, MBBS, helen.miles@health.qld.gov.au
Helen Miles, MBBS
- Recruiting
Westmead Childrens Hospital
Sydney, New South Wales
Melanie Jansen, melanie.jansen@health.nsw.gov.au
Melanie Jansen
- Recruiting
Townsville Hospital
Townsville, Queensland, 4814
Melita Trout, MBBS
About this study
Official title: Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
- 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
- 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
- Conditions
- Trauma, Hemorrhage, Coagulopathy, Pediatrics
- Being tested
- Fibrinogen Concentrate, Cryoprecipitate
- Keywords
- Fibrinogen Concentrate, Cryoprecipitate
- Medical subject headings
- Wounds and Injuries, Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen ConcentrateDrug
Also called Riastap
Experimental
CryoprecipitateDrug
Comparator
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Cryoprecipitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
Time to fibrinogen replacement
Measured: 3 Hours
Secondary outcomes (7)
Transfusion Requirements
In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs
Measured: Up to 48 hours after Trauma Unit presentation
Duration of bleeding episode or time until surgical control
Duration bleeding episode
Measured: It is anticipated that haemorrhage control will be achieved within 12 hours
Intensive Care Unit LOS
ICU LOS
Measured: 1 Year
Hospital LOS
Hospital LOS
Measured: 1 Year
Adverse Events
Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications
Measured: 1 Year
All Cause Mortality
Mortality at 4, 6, 24 hours and up to 90 days
Measured: Up to 90 Days
Functional Outcomes GOS-E Paediatrics
Functional Outcome Measures at 60 and 90 Days
Measured: Up to 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gold Coast Hospital and Health Service
- Sponsor type
- Other government
- Collaborators
- Emergency Medicine Foundation, National Blood Authority, Australian Red Cross
- Responsible party
- Principal investigator, Dr James Winearls, BSc (Hons), MBBS, MRCP, FCICM, Gold Coast Hospital and Health Service
- Investigators
- Shane George, MBBS, Principal investigator, Lady Cilento Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508141
- Sponsor's protocol ID
- FEISTY Jnr 1
- Acronym
- FEISTY Jnr
- Status last verified
- Jun 2020
- First submitted
- 23 Mar 2018
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35508351
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage in Children: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03508141
- Acronym / sponsor ID
- FEISTY Jnr / FEISTY Jnr 1
- Conditions
- Trauma, Hemorrhage, Coagulopathy, Pediatrics
- Keywords
- Fibrinogen Concentrate, Cryoprecipitate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Gold Coast Hospital and Health ServiceOther government
- Collaborators
- Emergency Medicine Foundation, National Blood Authority, Australian Red Cross
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrinogen Concentrate | Experimental | Drug: Fibrinogen ConcentrateFibrinogen 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 |
| Cryoprecipitate | Active comparator | Drug: CryoprecipitateFibrinogen 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 |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen ConcentrateAlso: RiastapExperimental | Drug | Fibrinogen Concentrate |
| CryoprecipitateComparator | Drug | Cryoprecipitate |
Primary outcome
Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement
Time frame: 3 Hours
Time to fibrinogen replacement
7 secondary outcomes
Transfusion Requirements
Time frame: 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
Intensive Care Unit LOS
Time frame: 1 Year
Hospital LOS
Time frame: 1 Year
Adverse Events
Time frame: 1 Year
All Cause Mortality
Time frame: Up to 90 Days
Functional Outcomes GOS-E Paediatrics
Time frame: Up to 90 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Derived from this study: PubMed 35508351George 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shane George, MBBS principal investigator
Lady Cilento Children's Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fibrinogen Concentrate and Cryoprecipitate in people with Trauma and Hemorrhage, run by Gold Coast Hospital and Health Service at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Winearls, MBBS (+61756875684, james.winearls@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement (time frame: 3 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03508141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.